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

Catalog Number TVTUNK

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

Patient Problems Obstruction/Occlusion (2422); 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 the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent."the patient demographic info: age, weight, bmi at the time of index procedure? name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? were any concomitant procedures or implantation of other devices performed? were there any intra-operative complications? onset time of the obstructive voiding from the index procedure? what was causing the obstruction? is a remaining vaginal portion of tape planned to be removed on ¿(b)(6) 2018 ¿? what is the indication to remove a remaining vaginal portion of tape? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? other relevant patient history/concomitant medications product code and lot number? note: adverse event of obstructed voiding and midline division in 2015 was reported via medwatch report 2210968-2018-77598.

Event Description

It was reported that the patient underwent an unknown gynecological surgical procedure on (b)(6) 2001 and the mesh was implanted.The patient experienced obstructed voiding since operation.The patient underwent a midline division in 2015.It was also reported that the patient underwent a midline of 1cm of tape removal in 2017.Additional information has been requested.

• 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; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8144747
• MDR Text Key: 129747320
• Report Number: 2210968-2018-77599
• 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: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention