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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS 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 Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Incident date was not provided. Date of manufacture: since the lot number was not provided, this information cannot be determined.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. Additional information has been requested, but not yet received. Product was used for therapeutic treatment. The preoperative diagnosis was grade iii cystocele and grade ii rectocele. The postoperative diagnosis was grade iii cystocele, grade ii rectocele, and grade iii enterocele. The procedure performed was a mesh cystocele and rectocele repair with mesh implantation both anteriorly and posteriorly. At the same time, an additional procedure was performed. The preoperative and postoperative diagnosis was recurrent cystocele, recurrent rectocele, and need for urethral support in conjunction with anterior repair and posterior repair. The procedure performed was a tension-free vaginal tape sling and cystoscopy. The patient underwent an additional procedure on (b)(6) 2006. The preoperative and postoperative diagnosis was grade ii enterocele. The procedure performed was an abdominal sacral colpopexy.

 
Manufacturer Narrative

Tracking #pe:(b)(4).

 
Event Description

Alleged complications post device implant: 2010: vaginal discharge, mesh excision and granulation cauterization. Mesh revision surgery: 2012 cystocele repair and enterocele repair, and vaginal cuff suspension, excision of exposed mesh, posterior colporrhaphy, perineorrhaphy and cystoscopy.

 
Manufacturer Narrative

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 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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6393654
MDR Text Key69557331
Report Number9615742-2017-05037
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
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 02/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received02/08/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/09/2017 Patient Sequence Number: 1
Treatment
BSC ADVANTAGE, MESH
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