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

Model Number SYM15

Device Problems Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Inflammation (1932); Necrosis (1971); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hernia. It was reported that after the implant, the patient experienced failure of mesh, mesh shrinkage, recurrence, adhesions, pain, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesion, bowel deserosalization, bowel erosion, defective mesh, mental pain, disability, impairment, loss of enjoyment of life, and enterotomy. Post-operative patient treatment included revision surgery, bowel resection, and removal surgery.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• 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: 12954878
• Report Number: 9615742-2021-02464
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190368
• UDI-Public: 10884521190368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2021
• Device Model Number: SYM15
• Device Catalogue Number: SYM15
• Device Lot Number: PQB0691X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• 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 Sex: No Answer Provided
• Patient Outcome(s): Required Intervention; Disability