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

Model Number PCO2520OSX

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Hernia (2240); Impaired Healing (2378); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: abstack20s sht 5mm sgl use abs dev 20 (lot # n3j1174vx), abstack20s sht 5mm sgl use abs dev 20 (lot # n3d0108vx).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 ventral hernia.It was reported that after implant, the patient experienced recurrence, infection, necrotizing acute inflammatory changes, and open draining wound.Post-operative patient treatment included revision surgery and surgery to remove mesh.Information received indicates the patient is deceased.The reporter stated the device did not cause or contribute to the event.

• 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: 12112234
• MDR Text Key: 260061871
• Report Number: 9615742-2021-01656
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179820
• UDI-Public: 10884521179820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110816
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: PCO2520OSX
• Device Catalogue Number: PCO2520OSX
• Device Lot Number: PMC00486
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• 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