Home » Warning Cites Complaint Handling After Fecal Matter Exposure
Warning Cites Complaint Handling After Fecal Matter Exposure
ConvaTec failed to document its adverse event decision for a complaint about a patient exposed to fecal matter on a skin grafting after a “balloon came out, half inflated,” an FDA warning letter says. The company’s representative performed testing and discovered a hole “in the area between the finger pocket and the balloon body, on the outside surface,” which the company designated a product issue.
The GMP Letter
The GMP Letter
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