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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM9
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Granuloma (1876); Necrosis (1971); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Foreign Body In Patient (2687); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: abstack30x abs fixation device30 tacks, (lot # n6h0363mx). (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 hernia. It was reported that after the implant, the patient experienced fibroconnective soft tissue, degenerative changes, calcification, necrosis, foreign body reaction, fibrous tissue, abdominal pain, adhesions, foreign body material, scar tissue, granuloma, pain, meshoma, neuroma/neuralgia, palpable nodule, mesh rolled, diastasis, and histiocytic response. Post-operative patient treatment included revision surgery, diagnostic laparoscopy, biopsy of foreign material, removal of foreign body abdominal wall, removal of granuloma, neurectomy, excision of left inguinal nerves, meshoma removed, debridement, multiple hernia repairs, partial removal of mesh, and hernia repair with new mesh.

 
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Brand NameSYMBOTEX
Type of DeviceMESH, 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 Key10446084
MDR Text Key204172415
Report Number9615742-2020-01893
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYM9
Device Catalogue NumberSYM9
Device LOT NumberPRB2303X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/02/2017
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: 08/24/2020 Patient Sequence Number: 1
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