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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number URETEXTO2
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Breast Cancer (1759); Cellulitis (1768); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Incontinence (1928); Pain (1994); Weakness (2145); Cramp(s) (2193); Discharge (2225); Anxiety (2328); Distress (2329); Injury (2348); Disability (2371); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191); 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 prolapsed uterus and urinary incontinence. It was reported that after implant, the patient experienced device failure, pain, bleeding, protrusion, fear of sexual intercourse, upset emotional distress, embarrassment, uterus again bulging, inability to lift or strain, recurrent urinary incontinence, recurrent prolapse, erosion, stage i breast cancer, hypertension, and vaginal pain. Post-operative patient treatment included hysterectomy, device removal, and estrogen cream.

 
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Brand NameMESH SOFRADIM - URETEX
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 Key8697967
MDR Text Key147993763
Report Number9615742-2019-02189
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK041176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2011
Device MODEL NumberURETEXTO2
Device Catalogue NumberURETEXTO2
Device LOT NumberSGH00297
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/01/2006
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: 06/13/2019 Patient Sequence Number: 1
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