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

Model Number UNKNOWN PROGRIP MESH PRODUCT

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Hernia (2240); Unspecified Tissue Injury (4559)

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 a recurrent incisional hernia.It was reported that after implant, the patient experienced dense omental adhesions, chronic inflammation, mesh contraction, mesh retraction, recurrence, and mesh migration.Post-operative patient treatment included revision surgery, hernia repair with new mesh, primary closure of fascia, separate hernia repair with no mesh, and mesh explant.

• Brand Name: UNKNOWN PROGRIP MESH PRODUCT
• 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: 11141414
• MDR Text Key: 225826551
• Report Number: 9615742-2021-00142
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROGRIP MESH PRODUCT
• Device Catalogue Number: UNKNOWN PROGRIP MESH PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• 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