MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX MESH PRODUCT

Catalog Number URETEX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 11/23/2009

Event Type  Injury  

Event Description

Procedure: stress ui/pelvic organ prolapse.According to the reporter: the patient alleged injury.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The indication for implantation of transvaginal mesh in this patient is stress urinary incontinence (sui) and relaxed vaginal outlet.The postoperative complications that this patient developed following transvaginal placement of surgical mesh were vaginal hysterectomy, vaginal vault suspension, posterior repair, perineoplasty, pelvic pain, adhesions and left lower quadrant pain with history of adhesions in the pelvis.The complications post second additional surgery were urinary urgency, back pain, suprapubic discomfort, pain with intercourse, sui and urethral hypomobility with.Additional implant surgery for stress incontinence.

• Brand Name: URETEX MESH PRODUCT
• Type of Device: URETEX MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3952009
• MDR Text Key: 4607780
• Report Number: 9615742-2014-00225
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 59