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Product complaint # (b)(4) additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information provided believed to be approx 6 reactions in short run of time.Photographs and de-identified patient details to follow.If other, describe mostly leg graft sites, op note doesn¿t mention what sutures were used, patient did have a belovac drain placed in the leg.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? yes, facility name of original implant (b)(6), was device explanted? true, hardware/explant removal due to: skin reaction, did patient require revision surgery? true, reason for revision surgery.Skin wound debridement for one patient after prineo removed all skin upon removal of blistering reaction, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? one patient reportedly had plastic surgeon involvement and debridement of wound after prineo removal peeled all skin off.Patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? wound healing complications, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe as above, is the patient part of a clinical study unknown, 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.What was the procedure date? when was the prineo product removed from the patient? were any cultures taken? results? please describe how was the adhesive was applied.How was the wound cleaned and dried prior to prineo application? 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 lot of products used? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.No product is 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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