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

Model Number	SYM8OS
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7937449
• Report Number: 9615742-2018-02250
• Device Sequence Number: 19046772
• Product Code: FTL
• UDI-Device Identifier: 10884521190627
• UDI-Public: 10884521190627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: SYM8OS
• Device Catalogue Number: SYM8OS
• Device Lot Number: PNL0142X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/12/2019; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYM1510OS STEX SKIRT 15X10 CM X1 (LOT# POA0511X)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 116