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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 Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Granuloma (1876); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Ulcer (2274); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); Intermenstrual Bleeding (2665); 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 because of newly received information - exemption number: e2013003. 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 uterine prolapse, cystocele, rectocele, stress urinary incontinence. It was reported that after implant, the patient experienced vaginal bleeding (blood loss), vaginal discharge, foreign body in patient, granuloma, erosion of the mesh at the level of the vaginal apex, pelvic pain, dyspareunia, pain, infection, unspecified bowel problems, blood loss, unspecified neuromuscular problems, stress urinary incontinence, pelvic organ prolapse, abdominal pain, peritoneal vaginal fistula, infection, vaginal scarring (scar tissue), adhesions, inflammation, ulcer, uti, dysuria, abdominal pressure, urinary frequency, back and hip pain, suprapubic tenderness, slightly tender incision, right costovertebral angle tenderness, major depressive disorder, problems concentrating, forgetfulness, suicidal thoughts, generalized anxiety, suture erosion at the vaginal apex, palpable painful areas (vaginal apex), right flank pain, abnormal vaginal bleeding requiring areas cauterized every couple of months, frustration, always needing to have pad on, peritoneal vaginal fistula requiring removal, menopausal atrophy of the vagina, vaginal defect on the right side of the vaginal apex, extensive omental adhesion attaching the omentum to the upper and lower abdomen, bladder, right and left pelvic side wall, cramping, mesh exposure through vaginal wall and multiple non-surgical and surgical interventions. The device had been used with suprapubic catheter, davol drain, and align urethral support system retropubic.
 
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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 Key8670215
MDR Text Key147047895
Report Number9615742-2019-01795
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2014
Device Model NumberUGY1510
Device Catalogue NumberUGY1510
Device Lot NumberPJE00354
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
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: 06/05/2019 Patient Sequence Number: 1
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