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

Model Number SYM1510OS

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

Patient Problems Adhesion(s) (1695); Anemia (1706); Cyst(s) (1800); Hematoma (1884); Nausea (1970); Pain (1994); Scarring (2061); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371); Blood Loss (2597); No Code Available (3191)

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 hernia.It was reported that after implant, the patient experienced severe adhesions, bowel adhesion, mesh "rolled-up", severe pain, inability to work, partial excision, fascia debridement, nausea, scarring and disfigurement.Treatment provided for these conditions include surgical revision of the mesh.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 implant, the patient experienced severe adhesions, bowel adhesion, mesh "rolled-up", abdominal wall hematoma, chronic acute blood loss, anemia, bilateral simple renal cyst, severe pain, inability to work, nausea, scarring and disfigurement.Post-operative patient treatment included revision surgery, partial excision, fascia debridement, consider repeat ultrasound in 6-12 months and monitoring kidney function.

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 implant, the patient experienced severe adhesions, bowel adhesion, mesh "rolled-up", abdominal wall hematoma, chronic acute blood loss, anemia, bilateral simple renal cyst, severe pain, inability to work, nausea, scarring, mass, pelvic free fluid and disfigurement.Post-operative patient treatment included revision surgery, partial excision, fascia debridement, consider repeat ultrasound in 6-12 months and monitoring kidney function.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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
• MDR Report Key: 7937445
• MDR Text Key: 122792561
• Report Number: 9615742-2018-02249
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190399
• UDI-Public: 10884521190399
• Combination Product (y/n): N
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: SYM1510OS
• Device Catalogue Number: SYM1510OS
• Device Lot Number: POA0511X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019
• Supplement Dates FDA Received: 11/12/2019; 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYM8OS STEX SKIRT 8 CM X1 (LOT# PNL0142X)
• Patient Outcome(s): Required Intervention
• Patient Weight: 116