MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Migration (4003)

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Not Applicable (3189)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Date and name of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications.Product code and lot #.What is physician¿s opinion as to the etiology of or contributing factors to this event the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? describe any medical/surgical intervention for exposure including dates and surgical findings.What is the patient's current status? to date it has been reported that the device will not be 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 a patient underwent a gynecological procedure in 2015 and mesh was implanted.The mesh had good impact on bladder symptoms, but the patient experienced some discharge and palpable mesh extrusion in right par-urethral recess.The patient underwent localized excision of visible mesh and closure of defect on (b)(6) 2020.The patient was asymptomatic and completely healed at 6 week review.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to fda: 12/15/2020.Additional information: h6.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10824448
• MDR Text Key: 217926724
• Report Number: 2210968-2020-08970
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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: 12/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention