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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: closure with three layers of stratafix.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? yes, facility name of original implant? (b)(6), was device explanted? false, hardware/explant removal due to: dermabond prineo, did patient require revision surgery? false, reason for revision surgery.Detached distal from the patella on the tibia, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? surgeon removed dermabond prineo completely and put staplers on top on the ward, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe: staplers and another wound dressing, is the patient part of a clinical study: unknown, additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Did the patient fall? or was there an event during rehab post op? is photo available of patient dehiscence? what was the procedure date? what date /day post op was the reaction noted? 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? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Product lot of product used? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis? name of surgeon? 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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Product complaint # (b)(4).Additional information: d 4.Primary udi number.Additional information has been requested and received.Did the patient fall? we don¿t know.Or was there an event during rehab post op? we don¿t know.Is photo available of patient dehiscence? no.What was the procedure date? we don¿t know.What date /day post op was the reaction noted? we don¿t know.Please describe how was the adhesive was applied.As it¿s written in the ifu what prep was used prior to, during or after adhesive use? disinfection, cleaning, drying before, waiting until is dry after.Was a dressing placed over the incision? if so, what type of cover dressing used? not that i¿m aware off.Patient demographics: initials / id, gender, age or date of birth; bmi we don¿t have any information.Patient pre-existing medical conditions (ie.Allergies, history of reactions) - no product lot of product used? we don¿t know.Current patient status.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.Name of surgeon? dr (b)(6).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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