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

Model Number	PCOPM15H35
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9630956
• Report Number: 9615742-2020-00238
• Device Sequence Number: 10888098
• Product Code: FTL
• UDI-Device Identifier: 10884521177765
• UDI-Public: 10884521177765
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 64