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

Model Number PCOPM15H35

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Nausea (1970); Swelling (2091); Tachycardia (2095); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 parastomal hernia.It was reported that after implant, the patient experienced serosal tears, infection, erosion, abscess, adhesions, fluid collection, bacterial infection, tachycardia, abdominal pain, nausea, bloating, discomfort, redness, swelling, purulent bloody drainage, bilious feculent material, fibrinous exudate, small bowel obstruction, and recurrence.Post-operative patient treatment included small bowel resection, incision and drainage of abdominal wall abscess, lysis of adhesions, relocation of ileostomy, repair of enterotomy, debridement of wound, removal of portion of mesh, drain placement, transferred to icu, and revision surgery.

• 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: 9630956
• MDR Text Key: 176369462
• Report Number: 9615742-2020-00238
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177765
• UDI-Public: 10884521177765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081126
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Model Number: PCOPM15H35
• Device Catalogue Number: PCOPM15H35
• Device Lot Number: PLI00151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Date Device Manufactured: 09/22/2011
• 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): Hospitalization; Required Intervention
• Patient Weight: 64