MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number PCOPM20

Device Problems Fracture (1260); Defective Device (2588); Material Split, Cut or Torn (4008)

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, following parastomal hernia repair, the patient had an incarcerated - but vital - bowel loop through the mesh fracture.Patient came as emergency patient due to bowel "upstruction".A new mesh repair was performed to close the defect.This resulted in delay of surgery.

Manufacturer Narrative

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

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7706376
• MDR Text Key: 114574710
• Report Number: 9615742-2018-01656
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: 10884521177789
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K081126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention