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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS URETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number URETEXTO2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Incontinence (1928); Inflammation (1932); Pain (1994); Scar Tissue (2060); Injury (2348); Prolapse (2475); Blood Loss (2597); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect. Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form. 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 stress urinary incontinence. It was reported that after implant, the patient experienced recurrence, pelvic pain, dyspareunia, abnormal uterine bleeding, adhesions, urethral hypermobility and intrinsic sphincter deficiency, defecatory disorder secondary to rectocele, left bartholin gland inflammation, and vaginal scar tissue. Post-operative patient treatment included video urodynamic evaluation including noninvasive uroflowmetry, cystometrogram, sphincteric emg monitoring, abdominal leak point pressure measurement, pressure flow urodynamics, urethrocystography and video imaging, a transobturator mesh revision and cystoscopy, pubovaginal sling with align retropubic urethral support system, cystoscopy, and posterior colpoperineorrhaphy, an examination under anesthesia, excision of mesh on the left lateral wall of the vagina and left obturator space, excision of left inflamed bartholin gland, and cystoscopy, and laparoscopy with lysis of adhesions.
 
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Brand NameURETEX
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 Key8925443
MDR Text Key155346366
Report Number9615742-2019-02873
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041176
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 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2012
Device Model NumberURETEXTO2
Device Catalogue NumberURETEXTO2
Device Lot NumberSHC00038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
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: 08/23/2019 Patient Sequence Number: 1
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