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

Model Number PNP8X3

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

Patient Problems Abscess (1690); Hematoma (1884); Ischemia (1942); Scar Tissue (2060); 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 left inguinal hernia.It was reported that after the overlaying implant, the patient experienced hematoma, ischemia, clotted blood, scarring, abscess, recurrence, scar tissue, and spermatic cord involvement.Post-operative patient treatment included dissection of old mesh, mesh resuture to the inguinal floor, incision/drainage of hematoma, orchiectomy, hernia repair with new mesh, hernia repair with old mesh, chunks of clotted blood removed, j-prat drain placed, dissection of scar tissue, left ischemic testicle amputation, and spermatic cord resection.

• Brand Name: PARIETEX
• 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: 11861131
• MDR Text Key: 251925731
• Report Number: 9615742-2021-01343
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 20884521176437
• UDI-Public: 20884521176437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101519
• 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: 05/20/2021

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: PNP8X3
• Device Catalogue Number: PNP8X3
• Device Lot Number: SSA0137X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Date Device Manufactured: 01/19/2018
• 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
• Patient Weight: 93