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

Model Number TET1309D

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

Patient Problems Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Swelling (2091); Injury (2348); Disability (2371); 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 an umbilical hernia.It was reported that shortly after implantation, the patient experienced right testicular pain.

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 an umbilical hernia and bilateral inguinal hernia.It was reported that shortly after implantation, the patient experienced right testicular pain, temporary disability, postoperative neuropathy, ilio-inguinal nerve entrapment syndrome or scar tissue affecting the right ilioinguinal nerve, and symptoms consistent with ilioinguinal neuralgia.It was reported on (b)(6) 2015 the patient has reached mmi (maximum medical improvement), with aching right groin pain, and no issues lifting at work.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia and bilateral inguinal hernia.It was reported that shortly after implantation, the patient experienced right testicular pain, hernia pain, temporary disability, postop neuropathy, ilio-inguinal nerve entrapment syndrome or scar tissue affecting the right ilioinguinal nerve, swelling, and symptoms consistent with ilioinguinal neuralgia.Post-operative patient treatment included nerve block.

Manufacturer Narrative

Concomitant prod: tet1309d parietex 3d preshaped py 13x9 cm (lot# snd0531).If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8161053
• MDR Text Key: 130232073
• Report Number: 9615742-2018-02757
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180130
• UDI-Public: 10884521180130
• Combination Product (y/n): N
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: TET1309D
• Device Catalogue Number: TET1309D
• Device Lot Number: SND0531
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 88