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Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the patient reaction? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon no product available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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It was reported a patient underwent a hysterectomy and a removal of other things plus placement of a sling on (b)(6) 2024 and topical skin adhesive was used.Two days post op surgery had a reaction to adhesive.The reaction is still running it's course two weeks later.They had seven incisions where adhesive was used.The rash spread from their upper abdomen all the way down to their thighs and pubic region, very itchy and blistering (raised red bumps that pop and then crust over, they start at the hair follicle but then grow around causing raised and itchy weeping), when they removed the adhesive from the surface area and the prednisone it was doing better, as she comes off the prednisone the reaction is reoccurring.The first prescription started with three days with 60 mg, then three days at 40 mg then three days at 20 mg.The three days at 60 helped a lot, by the third day at 40 mg it was less effective, on the first day at 20 mg it came back.The one day at 20 mg they took another later that afternoon as the pain returned.The new prescription calls for 4 days at 40 mg and then three days at 20 mg.The facility does not have a plan further then the second prescription they are working with allergist.The patient told the surgeon in advance that she has a problem with adhesives.No product will be returned.Additional information has been requested.
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Product complaint # (b)(4).Additional information has been requested and received.Is a photo available of the patient reaction? yes if in your possession, may we have a copy of your operative report? not answered does ethicon have your permission to contact your surgeon? yes there were 7 incisions, but only six of them were closed with dermabond.The dermabond was applied on jan 3, itching began on jan 4, and by jan 5 it was clear that a rash was forming.The doctor declined to remove the dermabond at that time.Ointments were prescribed on jan 6th and applied 2-3 times daily, but the rash continued to get worse.I started 60mg prednisone on jan 10th.I finally convinced the surgeon to remove the dermabond on jan 11.The prednisone plus removal of the dermabond finally provided relief and stopped the rash from spreading.The rash went away from my pubic area first.I think that the dermabond was not as firmly attached due to regrowth of hair pushing the adhesive away from my skin.It was also the easiest to remove.Patient continuing to taper off the prednisone, my current dose is 5mg.Each time i decrease the prednisone, there is a bounce-back effect where the rash gets slightly worse (new itchy spots) but then it continues to improve after that.I am now one month post-surgery.Three of the incisions still itch, but the irritation is confined to the healing incision.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Was any surgical intervention performed? were any cultures taken? results? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? product code and/or lot of product used? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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