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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 SYM2015
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Pain (1994); Sepsis (2067); Hernia (2240); Discomfort (2330); Injury (2348); Ascites (2596); Abdominal Distention (2601); Bowel Perforation (2668); No Code Available (3191); Constipation (3274)
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 an incisional hernia. It was reported that after implant, the patient experienced incarcerated recurrent incisional hernia, adhesions, bulge with pain in supraumbilical skin, mild tenderness, omentum adherent to the midline incisional, and bowel adherent to mesh. Post-operative treatment included recurrent incarcerated incisional hernia repair with new mesh, partial removal of previous covidien mesh, and small bowel resection.

 
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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 Key8495175
MDR Text Key141318133
Report Number9615742-2019-01103
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,Followup,Followup,Followup
Report Date 12/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device MODEL NumberSYM2015
Device Catalogue NumberSYM2015
Device LOT NumberPPF0423X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 04/09/2019 Patient Sequence Number: 1
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