Evenflo Breast Pump Electrical Shocks Not Properly Investigated: FDA
The FDA has sent baby product maker Evenflo a warning letter for failing to investigate reports that some women received electric shocks while using its “Comfort Select” breast pumps.
The warning letter comes after an inspection of two Ohio plants in January, where FDA inspectors found that Evenflo has failed to establish required medical device reporting procedures for its breast pumps. The FDA says in the letter, sent August 25 and released on Tuesday, that it reviewed 37 complaints of breast pump problems and found that 18 of those complaints were never investigated by the company. At least three of those complaints were from women who reported receiving Evenflo breast pump shocks.
The FDA said it found a number of current good manufacturing practices problems at plants in Miamisburg and Piqua, Ohio. Besides not fully investigating all customer complaints, the FDA said the company was failing to validate that corrective actions it took to address problems actually worked, and did not verify that corrections to products did not adversely affect those products.
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The letter notes that in the months since the inspections, Evenflo has made an effort to correct all of the problems, and has done an adequate job of addressing most of them. However, the agency still appears to have some concern over Comfort Select breast pumps sold prior to December 2008, noting that the company has failed to address concerns about those devices.
The FDA also says the company still needs to develop medical device reporting (MDR) procedures for its breast pumps that identify, evaluate and report complaints that might be subject to federal MDR requirements.
Evenflo has 15 days to respond to the letter or it could face fines or other penalties.
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