MAUDE Adverse Event Report: MENTOR TEXAS OBTAPE SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Catalog Number 93-4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pocket Erosion (2013)

Event Type  Injury  

Manufacturer Narrative

At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: biopsy of vaginal wall tissue.Manufacturers reference number: (b)(4).

Event Description

It was reported that a (b)(6) caucasian female patient who underwent a urethral sling insertion procedure with a mentor obtape vaginal sling developed postmenopausal bleeding.As a result, the patient underwent treatment on (b)(6) 2019 to examine the device.A surgeon observed that there was erosion of the sling through the anterior vaginal wall.An incision was made around this area and it was sent for permanent biopsy.The biopsy results showed benign squamous mucosa and underlying stroma with nonspecific changes.Additionally, the results were negative for dysplasia or malignancy.

• Brand Name: OBTAPE SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12373829
• MDR Text Key: 268423941
• Report Number: 1645337-2021-09579
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2021

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 Catalogue Number: 93-4000
• Device Lot Number: 5599808
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2005
• 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): Required Intervention
• Patient Age: 54 YR