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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Breast Cancer (1759); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Anxiety (2328); Injury (2348); Prolapse (2475); Weight Changes (2607); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

Specific type of mesh product was not available. Procode chosen based on most common mesh procode reported between ftl and otn. 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 cystocele and stress urinary incontinence. After implant, the patient experienced worse incontinence, lower back pain, chronic abdominal pain. Symptoms occurred within six weeks of implant. The patient also experienced breast cancer, chronic constipation, cystocele recurrence, diverticulitis, dyspareunia, enterocele, hypertension, obesity, rectocele, infections, urinary retention, vaginal vault prolapse, and anxiety. Treatment included pelvic floor reconstruction in 2005, and prescription of zoloft/clozuphin for anxiety.

 
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Brand NameUNKNOWN 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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8167133
MDR Text Key130458192
Report Number9615742-2018-02759
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
Type of Report Initial
Report Date 12/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN MESH
Device Catalogue NumberUNKNOWN MESH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
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: 12/14/2018 Patient Sequence Number: 1
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