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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 UGYKA
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erosion (1750); Bruise/Contusion (1754); Purulent Discharge (1812); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chills (2191); Cramp(s) (2193); Discharge (2225); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Prolapse (2475); Skin Tears (2516); Dysuria (2684); Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038b) and is now being submitted on a 3500a form. Exemption number: (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 of cystocele, vaginal vault prolapse and stress urinary incontinence. It was reported that after implant, the patient experienced pain, nausea, recurrent prolapse, recurrent urinary tract infections, dysuria, lower abdominal cramping, urinary urgency, urinary frequency, fecal incontinence, nocturia, incomplete emptying of bladder, vaginal bruising, mesh erosion (at vaginal apex/proximal anterior wall/top of vagina at cervical vaginal junction/cuff), atrophic vaginitis, acute cystitis (inflammation), vaginal pressure, stricture, vaginal discharge, hyperkeratosis, cracking of skin on genitalia, infection, pelvic organ prolapse, extrusion, increased urinary stream, pressure and discomfort between the rectum and vagina, discomfort riding any distance in a car, small rectocele, fecal incontinence, feeling as though there was a small lemon down below that feels like pressure when she is standing which makes her want to sit down, left labial minora with small area of bruising, stage 1 vaginal prolapse, slight sense of stool trapping, minimal recurrent cystocele between 2 and 3, unspecified bladder issues, pelvic relaxation symptoms, digital defecation, introitus irritation, rectal pain, chills, backache, stricture above the cervix, cracking of the skin noted at the posterior fourchette from hyperkeratosis induced by the discharge from the eroded graft and yellow discharge around the graft. The device had been used with align® to urethral support system. Post-operative patient treatment includes multiple non-surgical interventions but no surgical interventions to date.
 
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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 Key8695512
MDR Text Key147878927
Report Number9615742-2019-02182
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/13/2019
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
Device Expiration Date08/31/2012
Device Model NumberUGYKA
Device Catalogue NumberUGYKA
Device Lot NumberZHI00366
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2007
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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