MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿; MESH, SURGICAL

Model Number P101015

Device Problem Mechanics Altered (2984)

Patient Problem No Code Available (3191)

Event Date 09/01/2007

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during procedure, while the mesh was implanted in the body, the mesh did not work.The patient undergone six surgeries but still the problem prevailed.The pieces of the mesh were still in the patient¿s body.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.Duplicate of (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• 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: 7826430
• MDR Text Key: 118552328
• Report Number: 9615742-2018-01943
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000115
• UDI-Public: 10884523000115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P101015
• Device Catalogue Number: P101015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2018
• 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