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

Model Number SYM2520

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Foreign Body Reaction (1868); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Ulcer (2274); Impaired Healing (2378); Respiratory Failure (2484); Fluid Discharge (2686); Fibrosis (3167); 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 a ventral incisional hernia.It was reported that after the implant, the patient experienced mesh deformation, abscess, adhesions, infection, recurrence, mesh migration, cellulitis, bacterial infection, granuloma, ulcer, granulation tissue, inflammation, fibrosis, foreign body reaction, (b)(6), pain, nausea, nonhealing wound, abdominal pain, purulent material, erythema, skin warmth, failure of mesh, fibrinous reactive tissue, respiratory failure, draining wound, disrupted mesh, and meshoma/ balling.Post-operative patient treatment included revision surgery, hernia repair with new mesh, admission to hospital, antibiotics, lysis of adhesions, removal of hernia sac, reduction of hernia contents, debridement of skin/ subcutaneous tissue/ muscle/ muscle fascia, abdominal wall component separation, placement of drains, closure of rectus fascia, debridement/ resection of skin/ subcutaneous stitch granuloma, fibrinous reactive tissue dissected, medication, and removal of mesh.

• 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: 11421445
• MDR Text Key: 234924227
• Report Number: 9615742-2021-00452
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190481
• UDI-Public: 10884521190481
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: SYM2520
• Device Catalogue Number: SYM2520
• Device Lot Number: PSF0900X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYM1510 STEX 15X10CM X1 (LOT # PQK1072X)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 134