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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 SYM15
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Perforation (2001); Sepsis (2067); Septic Shock (2068); Tachycardia (2095); Hernia (2240); Peritonitis (2252); Injury (2348); Obstruction/Occlusion (2422); Respiratory Failure (2484); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical product: unknown absorbatack (lot# unknown), unknown protack (lot# unknown). (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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, adhesions, infection, peritonitis, sepsis, perforated diverticulitis, septic shock, acute respiratory failure, pancytopenia, tachycardia, acute on chronic kidney disease, elevated lactate, and bowel obstruction. Post-operative patient treatment included revision surgery, admission to hospital, enterotomy repaired, icu, requiring vasopressor management, resuscitation, antibiotic, antiviral therapy, and mesh removal.

 
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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 Key10740912
MDR Text Key213215831
Report Number9615742-2020-02396
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,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYM15
Device Catalogue NumberSYM15
Device LOT NumberPPB0530X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/27/2020 Patient Sequence Number: 1
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