MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX SUPPORT PP TRANSOBTUR2 KIT X1; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number URETEXTO2

Device Problem Degraded (1153)

Patient Problem No Code Available (3191)

Event Date 05/21/2007

Event Type  Injury  

Manufacturer Narrative

Reference number: (b)(4).This event was previously reported under manufacturing report # 1219930-2015-00574.Based on additional information received, it has been determined that the product was manufactured at another facility; therefore, this report has been generated to capture the change.A supplemental has been filed for manufacturing report # 1219930-2015-00574 to indicate the change, referencing the new manufacturing report #.

Event Description

According to the reporter, the patient required a second procedure on (b)(6) 2008 due to exposed mesh.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received the procedure was a transvaginal hysterectomy with bilateral salpingo-oophorectomy, anterior and posterior repair, diagnostic cystoscopy and transobturator mid urethral sling under general anesthesia.

• Brand Name: URETEX SUPPORT PP TRANSOBTUR2 KIT X1
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5716894
• MDR Text Key: 47102904
• Report Number: 9615742-2016-00071
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: URETEXTO2
• Device Catalogue Number: URETEXTO2
• Device Lot Number: SGK00721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: 05/18/2016
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR