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

Model Number UNKNOWN SURGIPRO MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 an incisional hernia. It was reported that after implant, the patient experienced kinked bowel, necrosis, adhesions, bowel filled with liquid green material, dilated cecum, hemorrhagic colon mucosa, foreign body type granulomatous reaction, inflammation, fibrinopurulent exudate in bowel, and gangrenous appearance in bowel. Post-operative patient treatment included removal of mesh and debridement of entire fascia. Information received indicates the patient is deceased. The reporter stated the device did not cause or contribute to the event.

• Brand Name: SURGIPRO
• 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: 11435701
• MDR Text Key: 238354110
• Report Number: 9615742-2021-00519
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN SURGIPRO MESH
• Device Catalogue Number: UNKNOWN SURGIPRO MESH
• Device Lot Number: A2F418
• 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: 02/17/2021
• 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: 03/08/2021 Patient Sequence Number: 1