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

Model Number TEM1208GL

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735); Pain (1994); Anxiety (2328); Depression (2361); No Code Available (3191)

Event Date 05/13/2011

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, the patient experienced pain and issues after a hernia mesh implant.These issues increased where he was diagnosed with a staphylococcus infection and abscesses on his left groin.Re-occurring abscesses had to be surgically drained and the doctors found a rare form of staphylococcus lugdunensis.His pain persisted which led to having the mesh implant removed.While removing the mesh, the surgeon noticed the patient's iliohypogastric and ilioinguinal nerves were missing or was severed from his previous surgery.The patient also complained of sexual dysfunction, pain with erection and ejaculation, and can no longer have sex with partner.The patient had also been diagnosed with anxiety, depression, ptsd (post traumatic stress disorder) and bacterial overgrowth.

Manufacturer Narrative

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

• Brand Name: MESH SOFRADIM - PARIETEX¿ PROGRIP¿
• 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: 7669445
• MDR Text Key: 113403203
• Report Number: 9615742-2018-01490
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177680
• UDI-Public: 10884521177680
• Combination Product (y/n): N
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• 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

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SKF00386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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; Disability