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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 SYM1510OS
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, while cutting a specific for an open technique during an incisional hernia, the mesh was damaged.There was no patient injury.
 
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Brand Name
SYMBOTEX
Type of Device
MESH, 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 Key7642260
MDR Text Key112556442
Report Number9615742-2018-01378
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190399
UDI-Public10884521190399
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model NumberSYM1510OS
Device Catalogue NumberSYM1510OS
Device Lot NumberPRK1130X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/12/2018
Date Device Manufactured12/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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