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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 Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The preoperative and postoperative diagnosis was incomplete uterovaginal prolapse, cystocele, rectocele, and uterine prolapse, stress incontinence with urethral hypermobility, and perineal laxity. The procedure performed was a laparoscopic supracervical hysterectomy with sacrocervicopexy, coloplast t-sling tvt suburethral sling, modified posterior repair with perineoplasty, and cystourethroscopy with iv indigo carmine for incomplete uterovaginal prolapse, cystocele, rectocele, uterine prolapse, stress incontinence with urethral hypermobility, perineal laxity under general anesthesia. The patient underwent an additional procedure on (b)(6) 2010. The preoperative and postoperative diagnosis was mesh exposure following previous transvaginal suburethral sling. The procedure performed was a revision of suburethral sling with vaginoplasty and cystoscopy. The patient underwent an additional procedure on (b)(6) 2010. The preoperative and postoperative diagnosis was vaginal mesh suburethral sling erosion. The procedure performed was a vaginal mesh excision. Complications post pelvitex implant are in 2010: dyspareunia, noted to have a 3-mm area of mesh exposure in the midline. Revision of the sling mesh with vaginoplasty was recommended. Mesh revision (coloplast t-sling) surgery: in 2010 patient underwent revision of suburethral sling with vaginoplasty, cystoscopy for mesh exposure following previous transvaginal suburethral sling under iv sedation with local anesthesia. As per the available medical records, patient did not undergo revision of pelvitex mesh, however simultaneously placed coloplast mesh was revised on (b)(6) 2010, following mesh revision surgery, she developed complications such as erosion on (b)(6) 2010 that required additional surgery. Additional mesh revision (coloplast t-sling) surgery: (b)(6) 2010: underwent vaginal mesh excision for vaginal mesh suburethral sling erosion under general laryngeal mask airway anesthesia.
 
Manufacturer Narrative
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. The preoperative and postoperative diagnosis was incomplete uterovaginal prolapse, cystocele, rectocele, and uterine prolapse, stress incontinence with urethral hypermobility, and perineal laxity. The procedure performed was a laparoscopic supracervical hysterectomy with sacrocervicopexy, coloplast t-sling tvt suburethral sling, modified posterior repair with perineoplasty, and cystourethroscopy with iv indigo carmine for incomplete uterovaginal prolapse, cystocele, rectocele, uterine prolapse, stress incontinence with urethral hypermobility, perineal laxity under general anesthesia. It was reported that after implant, the patient experienced dyspareunia, mesh exposure, erosion, mesh revision, additional surgical procedures.
 
Manufacturer Narrative
Manufacturer reference number: (b)(4). Mfg date: since the lot number was not provided, this information cannot be determined. A good faith effort will be made to obtain the applicable information relevant to the report. 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The preoperative and postoperative diagnosis was incomplete uterovaginal prolapse, cystocele, rectocele, and uterine prolapse, stress incontinence with urethral hypermobility, and perineal laxity. The procedure performed was a laparoscopic supracervical hysterectomy with sacrocervicopexy, coloplast t-sling tvt suburethral sling, modified posterior repair with perineoplasty, and cystourethroscopy with iv indigo carmine. The patient underwent an additional procedure on (b)(6) 2010. The preoperative and postoperative diagnosis was mesh exposure following previous transvaginal suburethral sling. The procedure performed was a revision of suburethral sling with vaginoplasty and cystoscopy. The patient underwent an additional procedure on (b)(6) 2010. The preoperative and postoperative diagnosis was vaginal mesh suburethral sling erosion. The procedure performed was a vaginal mesh excision.
 
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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 Key6393616
MDR Text Key109652848
Report Number9615742-2017-05036
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 Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 12/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2014
Device Model NumberUGY1510
Device Catalogue NumberUGY1510
Device Lot NumberPJD00704
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2009
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: 03/09/2017 Patient Sequence Number: 1
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