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

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Erosion (1750); Not Applicable (3189)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a 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 in 2013? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? other relevant patient history/concomitant medications product code and lot # if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.

Event Description

It was reported that the patient underwent a sling procedure in 2013.The patient had an excellent outcome with respect to symptoms and patient was discharged at 6 months.In 2018, an incidental finding of small vaginal mesh exposure and small essentially asymptomatic mesh erosion.On (b)(6) 2018, the patient underwent excisions/partial burial of small erosion under general anesthesia.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 1/12/2019.

Manufacturer Narrative

Date sent to the fda: 01/12/2019.Additional information was requested, and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure? na.Name of initial surgical procedure in 2013? tvt.The initial approach for the index surgical procedure? na.Any concurrent procedure/device implantation? removal of mesh in 2018.Were there any intra-operative complications? na.Other relevant patient history/concomitant medications na.Product code and lot # na.If applicable, will product be returned, return date, tracking information na.What is physician¿s opinion as to the etiology of or contributing factors to this event na.What is the patient's current status? na.

• 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
• MDR Report Key: 8156946
• MDR Text Key: 130167531
• Report Number: 2210968-2018-77726
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention