Maxon

Description of Event or Problem

It was noted that during a laparotomy procedure, two sutures were placed at the proximal and distal ends and tied together at the center of the wound. Six days later, the patient experienced fascial dehiscence with small bowel evisceration. The central knot remained intact; however, the surgeon recalled that the suture was absent in the area of dehiscence. To resolve the issue, the overlying skin was closed with staples and the dehiscence was repaired using the same type of suture in a bring back laparotomy.

Additional Manufacturer Narrative

D10 Concomitant Product: 8886626761, 8886 6267-61 MAXON 0 GRN 75CM GS21X36, (Lot # UNKNOWN). Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.