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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN UGYTEX MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN UGYTEX MESH PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); No Code Available (3191)
Event Date 09/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Title: long-term outcomes of a randomized controlled trial comparing trans-obturator vaginal mesh with native tissue repair in the treatment of anterior vaginal wall prolapse source international urogynecology journal, 2019 (1-9). Date of online publication: 10 september 2019. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source, the aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh or native tissue repair. The study compared anterior colporrhaphy and trans-obturator vaginal mesh for the treatment of anterior vaginal wall prolapse. There were 75 women included in the study analysis, 39 of which were implanted with mesh. There were post-operative complications reported that require re-intervention including pelvic organ prolapse, mesh exposure, hematoma, stress urinary incontinence, dyspareunia and exposure. There were post-operative complications reported as well that did not require re-intervention including urinary tract infections, spontaneous/provoked pain and dyspareunia.
 
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Brand NameUNKNOWN UGYTEX MESH PRODUCT
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key9336715
MDR Text Key166831237
Report Number9615742-2019-03764
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN UGYTEX MESH PRODUCT
Device Catalogue NumberUNKNOWN UGYTEX MESH PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/18/2019 Patient Sequence Number: 1
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