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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UGY1510
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Diarrhea (1811); Fever (1858); Headache (1880); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Memory Loss/Impairment (1958); Nerve Damage (1979); Pain (1994); Perforation (2001); Pleural Effusion (2010); Rash (2033); Seroma (2069); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Stenosis (2263); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Disability (2371); Obstruction/Occlusion (2422); Hematuria (2558); Ascites (2596); Blood Loss (2597); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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. It was reported that after implant, the patient experienced severe pain unrelieved by analgesic medication, chronic infections refractive to antibiotic therapy, constant lower urinary tract obstruction and urinary retention, pulling sensations across the pelvic area, foul odor from vaginal mesh, mesh extrusion into the vagina, vaginal infections requiring antibiotic therapy, obstruction of the bladder neck and/ or outlet, bilateral pleural effusions, paralytic ileus, hematomas, abscess, ascites, fever, seroma, bacteria, anemia, vaginal bleeding, dyspareunia, intestinal gas, urinary incontinence, adhesions, rash across abdomen/ legs/ arms, headache, constipation, chronic cystitis, urinary tract infections, disability. Post-operative patient treatment included additional medical intervention.

 
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Brand NameMESH SOFRADIM - UGYTEX¿
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 Key9934228
MDR Text Key186776682
Report Number9615742-2020-00811
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,Followup,Followup
Report Date 05/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2009
Device MODEL NumberUGY1510
Device Catalogue NumberUGY1510
Device LOT NumberP24124G3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/01/2004
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: 04/08/2020 Patient Sequence Number: 1
Treatment
URETEXTO (LOT #: 24271TO), UGY1510 (LOT #: P24124G3)
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