Product complaint # (b)(4).Date sent to the fda: 08/01/2022.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 inc., 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.(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure other relevant patient history/concomitant medications were any concomitant procedures performed? onset date/time of the pain from surgery location and character of the pain? is there any specific activity that precipitated the pain or eased the pain? was medical intervention given for the pain management? results? was the device removed? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer was the mesh placed? (onlay, retro-muscular, extra peritoneal or intra-abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) how much time from initial hernia repair to hernia recurrence? was there any triggering event prior to present recurrence? (e.G., weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? from the revision surgery, what are the surgical findings including: mesh location and integrity? any deficiency or anomaly of the mesh? if yes, please describe it.Any pictures available? product code and lot # what is the patient's current status?.
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