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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 SYM1510F
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fistula (1862); Tissue Damage (2104); No Code Available (3191)
Date of Event 11/22/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, postoperative from laparoscopic esophageal hernia surgery through laparoscopic nissen fundoplication, patient had tissue damage - fistulous hole on distal esophagus and the enterocutaneous fistula.The patient had to be re-hospitalized.An endoscopy and fistula treatment had to be performed to resolve the issue.
 
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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 Key9788229
Report Number9615742-2020-00547
Device Sequence Number714452
Product Code FTL
UDI-Device Identifier10884521190382
UDI-Public10884521190382
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K131969
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/04/2020
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 Date10/31/2021
Device Model NumberSYM1510F
Device Catalogue NumberSYM1510F
Device Lot NumberPQJ0405X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/18/2020
Initial Report FDA Received Date03/04/2020
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 Hospitalization; Required Intervention;
Patient Age46 YR
Patient Weight58
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