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

Model Number PCO3020

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Hernia (2240); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Foreign Body In Patient (2687); Cancer (3262); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: tet3030 parietex std 3d py 30x30cm x1 (lot# 99348tt3). 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 incisional hernia. It was reported that after the implant, the patient experienced unincorporated mesh, which was opened, and this appeared to be into the peritoneal cavity, infection/infected mesh, indurated tissue beneath it appeared to be a rind over the surface of the bowel, chronic granulation tissue, purulent material, adhesions, draining wound, mesh erosion, fistulous communication to the small bowel, bowel injury, murky fluid, attenuated tissue, foreign bodies in the anterior abdominal wall, large squamous cell cancer, recurrence, densely adhered mass, bowel showed less tendency to eviscerate from the abdominal cavity, abscess, open wound, mesh fragmented, area of fluctuance, chronic serositis, hemorrhage, necrosis, chronic draining tracts, fistula, and fluid collection. Post-operative patient treatment included revision surgery, excision of extensive dissection of the viscera, free this densely adherent mass from the anterior abdominal wall, adhesiolysis, excision of segment of bowel/fistula, wound vac, excision of mesh, excision of foreign bodies in the anterior abdominal wall, full-thickness excision of skin,/muscle/fascia, takedown of enterocutaneous fistula, small bowel resection with primary anastomosis, partial colectomy with end colostomy, partial omentectomy, excision of large squamous cell cancer, hernia repair with new mesh, abdominal irrigation/debridement, change of vacuum dressings, abdominal washout, incision/drainage of abscess, wound was copiously irrigated/debrided and packed with saline-soaked gauze, placement of drains, admission to hospital, and removal/irrigation of purulent material.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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: 12029159
• MDR Text Key: 258725862
• Report Number: 9615742-2021-01537
• 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

• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2004
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: B22148PCO32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• 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: 06/18/2021 Patient Sequence Number: 1