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

Model Number TEM3015G

Device Problems Material Erosion (1214); Material Perforation (2205); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Ulceration (2116); Hernia (2240); Injury (2348); Deformity/ Disfigurement (2360); Impaired Healing (2378); Blood Loss (2597); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt. due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.(b)(4).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 incisional hernias.It was reported that after implant, the patient experienced abdominal pain, infected mesh, nonhealing abdominal wound, ulceration, abdominal distention, mesh failure, pain, mental anguish, permanent and severe scarring and disfigurement, recurrence, mesh erosion, mesh contraction, infection, fat necrosis, fistula, seroma, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute chronic nerve damage and pain.Post-operative patient treatment included operations to locate and remove mesh, drainage of seroma, placement of wound vac, debridement, abdominoplasty, placement of mesh prosthesis, ultrasound guided peritoneal abscess drained, placement of new mesh, operations to attempt to repair organs, tissue, and nerve damage, and the use of pain control and other medications.

• Brand Name: 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: 9145731
• MDR Text Key: 161796303
• Report Number: 9615742-2019-03314
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177741
• UDI-Public: 10884521177741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: TEM3015G
• Device Catalogue Number: TEM3015G
• Device Lot Number: SME00523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Date Device Manufactured: 06/21/2012
• 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
• Patient Age: 66 YR
• Patient Weight: 103