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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH/15 CM X 10 CM MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH/15 CM X 10 CM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM1510OS
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the physician was having difficulty with adhering the mesh during a procedure. Additional information has been requested but not yet received.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information received indicated that there was no injury to the patient. The mesh was able to be implanted once fully hydrated and facing the appropriate direction within the cavity. The procedure was a laparoscopic ventral hernia repair. No further information has been received.
 
Manufacturer Narrative
(b)(4). Additional information:the reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.
 
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Brand NameSYMBOTEX COMPOSITE MESH/15 CM X 10 CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
matthew amaral
60 middletown ave
north haven, CT 06473
2034926373
MDR Report Key5888519
MDR Text Key52511574
Report Number9615742-2016-00110
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM1510OS
Device Catalogue NumberSYM1510OS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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