On August 14, 2014, the FDA issued a class one recall for Expression, an intranasal splint. Expression is made by Enhancement Medical and is a hyaluronic acid gel to be used as an intranasal splint following nose surgery or trauma.
Hyaluronic acid, a naturally occurring compound, is used in many medical products and can be readily reversed with hyaluronidase. The FDA issues class one recalls when use of the recalled device may reasonably result in serious injury or death.
Expression Use Linked With Numerous Adverse Events
MassDevice reports that Enhancement Medical is unable to ensure that Expression is manufactured correctly and some lots might contain higher concentrations of hyaluronic acid while other lots of Expression where seen bubbling after sterilization, a potential sign of contamination.
The FDA is recalling all lots of Expression manufactured between September 2012 and June 2014, according to a release by the FDA. BioSpace reports that the recall covers all lots of Expression ever manufactured. Enhancement Medical reports that is has received complaints regarding the following adverse events in people treated with Expression.
- Bumps and Lumps
- Inflammatory reactions
Forbes reports that the FDA and Enhancement Medical have received complaints that Expression is not readily reversed using hyaluronidase, possibly due to the increased concentration of hyaluronic acid in Expression. The FDA reports that one person was left with an obvious deformity after reversal of Expression failed.
FDA Found Numerous Issues with Expression and Enhancement Medical
In a letter to Enhancement Medical, dated June 4, 2014, the FDA noted many problems were found during an inspection of the plant that manufactures Expression. The letter notes:
- Expression is not tested to ensure it contains the proper concentration of hyaluronic acid
- Enhancement Medical failed to handle and investigate complaints about adverse events associated with Expression in the proper manner
- Enhancement Medical had not performed any quality audits
- Multiple documents were found referring to Expression as an injectable filler, Expression has only been approved as an intranasal splint
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More than half a million trucks and SUVs have been recalled by Chrysler for manufacturer defects.
General Chrysler Recall Information
According to the Houston Chronicle, Fiat Chrysler is currently recalling more than 566,000 trucks and SUV due to reliability concerns.
So far this year, the recently merged company has issued 33 worldwide recalls resulting in 6.4 million recalled vehicles; 27 recalls include 5.1 million vehicles, which are in the U.S. market.
8 out of the 27 recalls, however, were announced prior to any consumer problems being reported.
Chrysler had 7.7 million vehicles recalled in 2002.
In an annual Consumer Report Magazine, 28 brands were ranked based on a Consumer Reports’ survey on reliability. Dodge, Ram, Fiat, and Jeep (all brands of Chrysler) were among the lowest scoring.
Ram Truck Recalls
- Vehicles included in the recall are 382,000 Ram 2500 and 3500 Trucks. Also in recall are chassis cabs manufactured between 2010 and 2014 for the Ram 4500 and 5500.
- These trucks have a 6.7-liter Cummins diesel engine that is the cause of the recall. The fuel heater terminal can begin to break down and cause overheating, fuel leaks, or fires.
- Consumers are advised to check for an odor of diesel fuel.
- No injuries or fires have been reported due to this issue.
- Chrysler dealers are able to fix the problem by installing an upgraded fuel heater terminal and fuel heater housings may also be replaced.
- Chrysler will notify consumers in December.
- Approximately 184,000 2014 Jeep Grand Cherokees and Dodge Durango SUVs are being recalled.
- In these vehicles, the stability control is being disabled by interrupted communications if debris covers the steering column control module’s circuit board.
- Dealers were receiving complaints about the electronic stability control warning lights being on.
- No crashes or injuries have been reported in connection with this problem.
- This problem can be fixed by upgrading the software on the SUVs.
- Customers will be officially notified in December.
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About the Oil Rig Fire
The incident occurred approximately at 6:45PM on Friday, October 24th, off Highway 97 near Tilden, about 70 miles from San Antonio.
According to KSAT, a Pioneer Natural Resources oil rig involved with the Eagle Ford Shale caught on fire. No oil spilled during the fire.
Five workers were on the rig when the fire started, according to a Pioneer Representative – other workers were able to put the fire out and called emergency services.
The five workers were eventually transported to San Antonio Military Medical Center by medical helicopters; however, the condition of the five workers has not been released.
The company has started investigating the accident. At this time the cause of the fire is unknown.
Oil and Gas Extraction Injury Statistics
- The Occupational Safety and Health Administration (OSHA) recorded 823 deaths in the oil and gas extraction industry between 2003 and 2010.
- The fatality rate for this industry is seven times greater than the rate of all U.S. industries.
- The most common causes of death for oil and gas workers are:
- Vehicle accidents
- Struck by object
- Confined spaces
- Chemical exposure
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