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

Model Number PCOPM20

Device Problem Torn Material (3024)

Patient Problems Tissue Damage (2104); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 09/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter,following a laparoscopic repair of a parastomal hernia procedure using a modified sugarbaker operative approach, the mesh was damaged.The surgeon observed a fracture of the mesh corresponding to the translucent stripe, where this originally covered the hernia defect.There was tissue damage and the patient experienced bowel obstruction as a result of the product problem.The surgical time was extended 30 minutes or more and the event also resulted to an extended patient hospital stay.The patient underwent reoperation for parastomal hernia to resolve the issue and to prevent permanent impairment.

Manufacturer Narrative

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

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: 7638025
• MDR Text Key: 112331378
• Report Number: 9615742-2018-01365
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Device Lot Number: PPH0355X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR