Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
|
The end user called to rule out the possible cause of an all over body rash she had been experiencing for the past 3 weeks.She had hives with itching from the tip of her head to the soles of her feet.Reportedly, she had seen a dermatologist twice, and said the health care professional was trying to determine the cause of the hives.She had used the convatec product for 4 years, and her usual wear time was 3-4 days.The only accessory she occasionally used was medline remedy phytoplex powder.The dermatologist gave her a steroid shot, but she got worse and not better.The cause of the skin reaction was unknown and the rash persisted.The end user continued to use the product.No photo is available at this time.
|