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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Inflammation (1932)

Event Date 09/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.Please provide the patient's demographic information including age, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? were any concurrent devices implanted? were there any intra-operative complications? please provide the mesh exposure symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the vaginal and bladder exposures including dates and findings.Were any deficiencies or anomalies noted with mesh device? was any medical/surgical intervention provided for the bladder stones and/or recurrent cystitis? if so, please describe.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product code and lot number? surgeon¿s name? 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.(b)(4).Related events captured via 2210968-2022-08092 and 2210968-2022-08093.

Event Description

It was reported that a patient underwent a sling procedure on an unknown date in 2002 and mesh was implanted.In 2022, the patient has mesh sling erosion to vagina but also to the bladder.Symptoms in the form of bladder stones and recurrent cystitis.The patient underwent removal of the mesh sling in the vagina, but it was not possible to remove the mesh material in the bladder.The patient must have surgery to remove the mesh in the bladder with open surgery at a later date.Additional information has been requested.

• Brand Name: TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15519355
• MDR Text Key: 300997351
• Report Number: 2210968-2022-08094
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2022

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
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female