MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problem Difficult to Remove (1528)

Patient Problems Incontinence (1928); Pain (1994); Burning Sensation (2146); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure in 2014 and mesh was implanted.The patient experienced shooting, burning pain.There was no sign of tape erosion or extrusion following a cystoscopy, but a bit of prolapse was found.Video urodynamics shows occasional stress incontinence.The consultant advised the patient to not have the mesh removed, but the patient insisted and the mesh was removed on (b)(6) 2018.It was reported that the mesh removal was a difficult case and the bladder was damaged while removing the mesh.A sling mesh was placed.No additional information has been provided.

Manufacturer Narrative

(b)(4).The patient complained of urethral and perineal pain.The patient requested mesh removal and underwent complete removal of mesh on (b)(6) 2018 with laparotomy and vaginal approach.The patient experienced a bladder injury and catheter for two weeks.

Manufacturer Narrative

(b)(4).This medwatch report is being voided as it is a duplicate of medwatch report # 2210968-2018-72760.Please see medwatch report # 2210968-2018-72760 for all information regarding this event.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7507557
• MDR Text Key: 108087631
• Report Number: 2210968-2018-72753
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 06/19/2018; 06/28/2018
• Supplement Dates FDA Received: 06/25/2018; 07/09/2018
• 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