MAUDE Adverse Event Report: ETHICON INC. TVT* DEVICE; ELECTRODE, PACEMAKER, TEMP

Catalog Number 10041

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928)

Event Date 04/21/2022

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.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, gender, weight, bmi at the time of index procedure.Date and name of index surgical 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? onset date/time of the incontinence from the initial procedure? please describe any medical intervention required to treat the incontinence including medication name and results.When was the mesh exposure first noted by a physician? describe any medical/surgical intervention for the exposure including dates and findings.Were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? please confirm the product code and lot number.To date it has been reported that the device will not be returned.(b)(4).

Event Description

It was reported that a patient underwent a sling procedure on 04/21/2022 and mesh was implanted.The patient experienced erosion and urge incontinence.The vaginal portion of the mesh was removed on an unknown date.Additional information was requested.

• Type of Device: ELECTRODE, PACEMAKER, TEMP
• 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: 14876352
• MDR Text Key: 295057358
• Report Number: 2210968-2022-05002
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2022
• 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
• Patient Sex: Female