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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PARIETEX UGYTEX MESH MESH,SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION UNKNOWN PARIETEX UGYTEX MESH MESH,SURGICAL, POLYMERIC Back to Search Results
Model Number UNKPARUGYTEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Date 06/27/2007
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). (b)(4).

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. After the device was implanted, the patient began to experience complications including but not limited to extreme pain, discomfort, urinary problems, dyspareunia.

 
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Brand NameUNKNOWN PARIETEX UGYTEX MESH
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 06473
MDR Report Key6198203
MDR Text Key63082861
Report Number9615742-2016-00221
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/30/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberUNKPARUGYTEX
Device Catalogue NumberUNKPARUGYTEX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
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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