MAUDE Adverse Event Report: COVIDIEN PARIETEX COMPOSITE; MESH, SURGICAL, POLYMERIC

Model Number N/A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930); Impaired Healing (2378); Cancer (3262)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

The patient presents for evaluation of a draining abdominal wall sinus tract.The patient underwent radical cystoprostatectomy with neobladder formation about six years ago, after which he developed a wound infection and subsequent hernia.He then underwent laparoscopic converted to open ventral hernia repair with mesh.This was complicated by an abdominal wall abscess requiring opening of the wound.He ultimately ended up with a nonhealing wound with exposed mesh, which did not heal with conservative management with serial mesh debridement.About three years ago, the patient underwent mesh removal and ventral hernia repair with bilateral component separation and strattice mesh underlay.A portion of the wound opened after this operation but was closing steadily with wound care.However, he was subsequently found to have a sigmoid colon cancer after an admission for gi bleed.About two years ago, the patient underwent low anterior resection and excision of mesh.Since that time, he has gone back to the operating room on two occasions, both about a year ago, for non-healing wounds, associated with persistent mesh, which was excised at the time of surgery.The patient did well after his most recent operation but has developed a persistent draining sinus tract to the left of his lower midline incision.

• Brand Name: PARIETEX COMPOSITE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN; 60 middletown avenue; north haven CT 06473
• MDR Report Key: 5418788
• MDR Text Key: 37741234
• Report Number: 5418788
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: PCO3020
• Device Lot Number: PIF00074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1