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Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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: if other, describe knee prothesis, 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? unknown, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? infection, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, if yes, describe infection and second surgery to close skin, is the patient part of a clinical study unknown, additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Confirm, it was noted that the procedure date of (b)(6) 2025.No, the surgery was (b)(6) 2025.What date /day post op was the reaction noted? two weeks after the surgery was any prescription strength medication prescribed to address the infection? please specify? surgical cleaning, suturing, intravenous antibiotics: ciprofloxacine was any surgical intervention performed? yes were any cultures taken? results? yes.Pseudomona aeruginosa + please describe how was the adhesive was applied.According to the techniques recommended for the product.What prep was used prior to, during or after adhesive use? clean the skin with chlorhexdine, wait for it to dry, and then apply the adhesive was a dressing placed over the incision? if so, what type of cover dressing used? don´t remember.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no is the patient hypersensitive to pressure sensitive adhesives? no was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no patient demographics: initials / id, gender, age or date of birth; bmi.Eaf, 70 years old, bmi 34.7.Patient pre-existing medical conditions (ie.Allergies, history of reactions) no has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no product lot of prineo 22 used? i don´t have it current patient status.Good name of surgeon? dr.Sergio gonzalez rouse what is the physician¿s opinion as to the etiology of or contributing factors to this event? the patient has a closed varicose ulcer; she may have scratched it and introduced bacteria into the area is product available to return for analysis.No 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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