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

Model Number SYM2520

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

Patient Problems Corneal Pannus (1447); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Vomiting (2144); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Weight Changes (2607); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 hernia.It was reported that after the implant, the patient experienced recurrence, open wound, mesh migration, mesh folded, infection, gram + cocci, inflammation, panniculitis, pannus, weight loss, leukocytosis, abdominal discomfort, drainage from abdominal incision, purulent material, devitalized skin, abdominal pain, low-grade fever, nausea, emesis, granulation tissue, and abscess.Post-operative patient treatment included removal of mesh, incision/drainage of abscess, wound vac, takedown of adhesions, admission to hospital, antibiotics, irrigation/debridement of devitalized skin, two drains removed, wound packed open, removal of sutures, and hernia repair with new 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12253883
• MDR Text Key: 264332472
• Report Number: 9615742-2021-01853
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: SYM2520
• Device Catalogue Number: SYM2520
• Device Lot Number: PQH0598X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Date Device Manufactured: 09/15/2016
• 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: UNKNOWN ABSORBATACK (LOT#UNKNOWN)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 103