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

Model Number SYM2015

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

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scarring (2061); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: unknown absorbable 30 count (product id: unknown, lot number: n4a0541x). (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 abdominal hernia. It was reported that after implant, the patient experienced pain, scarring, dermatitis, induration, fibrosis, granulation, fistula, adhesions, non-healing wound, abdominal wound dehiscence, infection, retained foreign body, foreign body reaction, mesh migration, recurrence, intentional/ bowel obstruction, and perforation. Post-operative patient treatment included resection and additional surgery.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10750825
• MDR Text Key: 213616791
• Report Number: 9615742-2020-02424
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2016
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: PNJ0509X
• 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: 10/07/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/04/2013
• 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: 10/28/2020 Patient Sequence Number: 1