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

Model Number PCO2520X

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Anemia (1706); Purulent Discharge (1812); Erythema (1840); Foreign Body Reaction (1868); Inflammation (1932); Nausea (1970); Staphylococcus Aureus (2058); Vomiting (2144); Injury (2348); Blood Loss (2597)

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 incisional hernia. It was reported that after implant, the patient experienced a large abdominal wall abscess, purulent material, foreign body granulomatous inflammation, mrsa, inflammation, abdominal pain, erythema, nausea, vomiting, anemia, blood loss, and loose mesh. Post-operative patient treatment included revision surgery, admission to hospital, antibiotics/medication, wound vac, transfusion, and mesh removal.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10637122
• MDR Text Key: 210062815
• Report Number: 9615742-2020-02281
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/06/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/06/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/30/2013
• Device MODEL Number: PCO2520X
• Device Catalogue Number: PCO2520X
• Device LOT Number: PLH00403
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/16/2020
• 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: 10/06/2020 Patient Sequence Number: 1

Treatment

UNKNOWN ABSORBATACK (LOT#UNKNOWN)