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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS URETEX MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS URETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number URETEXSUP
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Discharge (2225); Distress (2329); Injury (2348); Prolapse (2475); Blood Loss (2597); No Code Available (3191); Cancer (3262); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of stress urinary incontinence and vulvar cyst. It was reported that after implant, the patient experienced pain, infections, granulation, erosion, bleeding, dyspareunia, discharge, emotional changes, distress, adhesions, cancer, chronic constipation, cystocele, enterocele, rectocele, urinary incontinence and spotting. Post-operative patient treatment included surgical revision of the mesh.
 
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Brand NameURETEX
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 Key9259897
MDR Text Key164417921
Report Number9615742-2019-03565
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012949
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2008
Device Model NumberURETEXSUP
Device Catalogue NumberURETEXSUP
Device Lot NumberC23115SUP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/01/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/31/2019 Patient Sequence Number: 1
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