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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 SYM1710E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Adhesion(s) (1695); Hematoma (1884); Hernia (2240); Injury (2348)
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 an incisional hernia.It was reported that after the implant, the patient experienced recurrence of hernia, hematoma, and adhesions.Post-operative patient treatment included revision surgery, debridement, removal of old mesh, small bowel resection, hernia repair with new mesh, component of separation, lysis of adhesions, and tissue transfer to the right and left as well as placement of biological mesh.
 
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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 Key10252153
Report Number9615742-2020-01503
Device Sequence Number3106819
Product Code FTL
UDI-Device Identifier10884521190412
UDI-Public10884521190412
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K131969
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/09/2020
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 Date12/31/2021
Device Model NumberSYM1710E
Device Catalogue NumberSYM1710E
Device Lot NumberPRA1704X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/17/2020
Initial Report FDA Received Date07/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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