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

Model Number PPDS12

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

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: lpg1510ar 10x15cm lp antmcl mesh rt (lot#unknown), lpg1510al 10x15cm lp antmcl mesh lt(lot# unknown), ppds1 510 mesh parietene ds 15x10cm x1(lot#unknown).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 an inguinal hernia.It was reported that after the implant, the patient experienced hernia recurrence, failure of mesh, pain, scarring, and inflammation.Post-operative patient treatment included revision surgery and placement of additional mesh.

• Brand Name: PARIETENE DS
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12374423
• MDR Text Key: 268365969
• Report Number: 9615742-2021-02083
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521553446
• UDI-Public: 10884521553446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163212
• 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: 08/26/2021

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 Expiration Date: 12/31/2020
• Device Model Number: PPDS12
• Device Catalogue Number: PPDS12
• Device Lot Number: ETA2395X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/26/2021
• Date Device Manufactured: 01/21/2019
• 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: 59 YR