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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/10/2016

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 for stress urinary incontinence on an unknown date and mesh was implanted.The patient experienced persisting pain and underwent complete mesh excision abdominally in 2016.The patient recovered completely with persisting stress urinary incontinence.The patient underwent an unspecified incontinence procedure on an unknown date.No additional information has been provided.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: ¿ the patient demographic info: age (b)(6), weight, bmi 39 at the time of index procedure ¿ date and name of initial surgical procedure no information available as treated elsewhere ¿ the diagnosis and indication for the initial surgical procedure? vaginal and pelvic pain ¿ what were current symptoms following the index surgical procedure? onset date? ¿ other relevant patient history/concomitant medications previous endometrial ablation / general analgesics ¿ what is physician¿s opinion as to the etiology of or contributing factors to this event mesh related fibrosis ¿ onset date/time of the pain from surgery immediately after insertion ¿ location and character of the pain? constant pelvic/suprapubic and vaginal pain ¿ has the pain intensity changed over time? increased ¿ describe medical/surgical intervention for pain and incontinence including dates and findings.¿ is the device available for analysis? probably not ¿ what is the patient's current status? improvement in symptoms please also provide us with an update with regards to the product return.¿ is the device available for return? no.

• 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; neuchatel
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7565119
• MDR Text Key: 109920833
• Report Number: 2210968-2018-73258
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

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?: Yes
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/21/2018
• 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
• Patient Age: 56 YR