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

Model Number UNKNOWN PARIETEX PRODUCT

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Discharge (2225); Injury (2348); Impaired Healing (2378)

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 an inguinal hernia.It was reported that after implant, the patient experienced infected mesh, hemorrhagic, purulent material, abscess, chronically draining cavity, mesh migration, granulation tissue, and open wound.Post-operative patient treatment included revision surgery, incision/ irrigation/ drainage of wound, and partial mesh removal.

• Brand Name: UNKNOWN PARIETEX 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: 10767499
• MDR Text Key: 214082517
• Report Number: 9615742-2020-02439
• 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: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Device Lot Number: SIA00010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• 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