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

Model Number SPM-35-W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Pain (1994); Scarring (2061); Injury (2348); 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 a hernia. It was reported that after implant, the patient experienced dense adhesions. Post-operative treatment included multiple revision surgeries.

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. (b)(4). 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 inguinal hernia. It was reported that after implant, the patient experienced dense adhesions and an adherent scar, pain, large right chest wall lesion and cyst. Post-operative treatment included multiple revision surgeries, exploration of left groin, partial removal of left inguinal hernia mesh with primary repair of left inguinal floor, and excision of mesh and cyst.

• Brand Name: MESH - SURGIPRO¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8714817
• MDR Text Key: 148518530
• Report Number: 1219930-2019-03593
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2009
• Device Model Number: SPM-35-W
• Device Catalogue Number: SPM-35-W
• Device Lot Number: A4M154
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/19/2019 Patient Sequence Number: 1