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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 SYM2012EF
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Pain (1994); Obstruction/Occlusion (2422); No Code Available (3191)
Date of Event 12/05/2019
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, post operative laparoscopic treatment of an umbilical hernia with intraperitoneal mesh inlay, it was noted that there was very pronounced adhesions of small intestine at the net with consecutive small intestine ileus (intestinal obstruction).Patient undergone emergency surgery which started as laparoscopic but converted to open surgery due to unusual extent of adhesions.Incident had caused pain to patient and adhesiolysis was done to resolve the issue.Extended incision was also reported.
 
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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 Key10493024
Report Number9615742-2020-01923
Device Sequence Number14271338
Product Code FTL
UDI-Device Identifier10884521190443
UDI-Public10884521190443
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K131969
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/04/2020
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 Model NumberSYM2012EF
Device Catalogue NumberSYM2012EF
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/19/2020
Initial Report FDA Received Date09/04/2020
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 Required Intervention;
Patient Age48 YR
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