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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX MESH PRODUCT

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SOFRADIM PRODUCTION URETEX MESH PRODUCT Back to Search Results
Catalog Number URETEX
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Discomfort (2330); Injury (2348)
Event Date 11/23/2009
Event Type  Injury  
Event Description

Procedure: stress ui/pelvic organ prolapse. According to the reporter: the patient alleged injury.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The indication for implantation of transvaginal mesh in this patient is stress urinary incontinence (sui) and relaxed vaginal outlet. The postoperative complications that this patient developed following transvaginal placement of surgical mesh were vaginal hysterectomy, vaginal vault suspension, posterior repair, perineoplasty, pelvic pain, adhesions and left lower quadrant pain with history of adhesions in the pelvis. The complications post second additional surgery were urinary urgency, back pain, suprapubic discomfort, pain with intercourse, sui and urethral hypomobility with. Additional implant surgery for stress incontinence.

 
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Brand NameURETEX MESH PRODUCT
Type of DeviceURETEX MESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-016 00
FR F-01600
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key3952009
MDR Text Key4607780
Report Number9615742-2014-00225
Device Sequence Number1
Product Code OTN
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberURETEX
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 Received06/25/2014
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 Initial

Patient TREATMENT DATA
Date Received: 07/15/2014 Patient Sequence Number: 1
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