MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO MESH, SURGICAL, POLYMERIC

Model Number SPM-35

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Ischemia (1942); Necrosis (1971); Staphylococcus Aureus (2058); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an umbilical hernia. It was reported that after implant, the patient experienced wound seroma, palpable masses above and below umbilicus filled with fluid, incarcerated recurrent hernia, small bowel obstruction, incarcerated segment of small bowel within hernia, involvement of the entire abdominal wall creating swiss cheese effect, defect measuring 20cmx20cm, recurrent incarcerated ventral hernia, a volvulizedsegment of jejunum was noted to be incarcerated, adhesions, infected mesh, small bowel mass, posterior mesh adherent to bowel, and multiple abscesses found in conjunction with the mesh. Post-operative treatment included incarcerated recurrent umbilical hernia repair with mesh, incarcerated recurrent ventral hernia repair with mesh, small bowel resection, anastomosis, lysis of adhesions, wound debridement of previous incision site, mesh revision surgery, removal of infected mesh, debridement of subcutaneous tissues and underlying skin,.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an umbilical hernia. It was reported that after implant, the patient experienced wound seroma, palpable masses above and below umbilicus filled with fluid, incarcerated recurrent hernia, small bowel obstruction, incarcerated segment of small bowel within hernia, involvement of the entire abdominal wall creating swiss cheese effect, defect measuring 20cmx20cm, recurrent incarcerated ventral hernia, a volvulizedsegment of jejunum was noted to be incarcerated, adhesions, infected mesh, small bowel mass, posterior mesh adherent to bowel, scar, and multiple abscesses found in conjunction with the mesh. Post-operative treatment included incarcerated recurrent umbilical hernia repair with mesh, incarcerated recurrent ventral hernia repair with mesh, small bowel resection, anastomosis, lysis of adhesions, wound debridement of previous incision site, mesh revision surgery, removal of infected mesh, debridement of subcutaneous tissues and underlying skin, creation of bilateral skin advancement flap, scar revision.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 8499541
• MDR Text Key: 141465453
• Report Number: 1219930-2019-02179
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SPM-35
• Device Catalogue Number: SPM-35
• Device Lot Number: A8F503
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/10/2019 Patient Sequence Number: 1