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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 01/12/2009
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, discomfort, urinary problems, and dyspareunia.

 
Manufacturer Narrative

Additional information was received indicating that the mesh involved in this incident is not a medtronic/covidien product. No further reports will be sent for this event. If information is provided in the future, a supplemental report will be issued.

 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6196685
MDR Text Key63059793
Report Number9615742-2016-00216
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,Followup
Report Date 11/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2016
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 Received11/07/2018
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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