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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION STEX RND THR 12CM X1 MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION STEX RND THR 12CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM12F
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 09/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). (b)(4).
 
Event Description
Procedure: abdominal wall hernia. According to the reporter: the patient has developed an allergic symptom. Ige levels are high. Eosinophil levels increased. The event occurred/was noticed after the surgery. The surgical time was not extended. There was no tissue damage. The incision site was not extended. Nothing fell into the patient's cavity. No bleeding occurred.
 
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Brand NameSTEX RND THR 12CM X1
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
sharon murphy
60 middletown ave
north haven, CT 06473
MDR Report Key6169278
MDR Text Key62211993
Report Number9615742-2016-00200
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM12F
Device Catalogue NumberSYM12F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
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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