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

Model Number SPM-35

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Purulent Discharge (1812); Gangrene (1873); Unspecified Infection (1930); Perforation (2001); Tachycardia (2095); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); 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 adhesions, infection and recurrence. Post-operative patient treatment included revision surgery.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9147024
• MDR Text Key: 160933191
• Report Number: 1219930-2019-05540
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/02/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 12/31/2017
• Device MODEL Number: SPM-35
• Device Catalogue Number: SPM-35
• Device LOT Number: A2M0656X
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/07/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 10/02/2019 Patient Sequence Number: 1