MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

Model Number UNKNOWN PARIETEX PRODUCT

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Perforation (2001); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after the implant, the patient experienced infected mesh, migrated mesh, mesh erosion, adhesions, enterotomy, serosanguineous fluid, recurrence, open wound, fistula, discomfort, mass, serous fluid, and obstructions. Post-operative patient treatment included revision surgery, removal of mesh, debridement of exposed mesh, lysis of adhesions, hernia repair with sutures, revision of mesh, evacuation of serosanguineous fluid, wound debridement, repair of enterotomies, small bowel resection, hernia repair with new mesh, serous fluid were liberated, and dissection of mesh.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11861160
• MDR Text Key: 251930878
• Report Number: 9615742-2021-01351
• 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,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/20/2021 Patient Sequence Number: 1

Treatment

UNKNOWN PROTACK (LOT#UNKNOWN)