Common device name: pouch, colostomy.Contact office address: dr.(b)(6).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.Fda registration number: (b)(4).
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The end user tried a sample product, which aggravated the pre-existing symptoms of burning, itching and the red skin condition started happening "all over my body".After a few hours, she went to the emergency room.She was diagnosed with contact dermatitis, was started on prednisone and was referred to an allergy doctor.The allergist prescribed an antihistamine (brand unknown) and topical cream to be used on the peristomal skin (brand unknown).The consumer left her pouch off for several days so that the cream could be applied.Thereafter, she was wore a non-company product and her skin was slowly improving.No photo is available at this time.
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