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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Insufficient Information (4580)

Event Date 08/21/2023

Event Type  Injury  

Event Description

Title: impact of defined risk factors on degree of urinary stress incontinence and sling outcome: a retrospective cohort analysis.The aim of our study was to identify risk factors for severe sui and determine whether successful the resolution of incontinence after a tvt procedure was different in women with a higher degree of sui.In total, 168 women were included in this retrospective cohort study, eight women were unavailable to return for the follow-up visit eight weeks after the tvt insertion due to the covid-19 pandemic.In total, 153 women underwent retropubic tvt insertion and 15 underwent transobturator tvt insertion.A total of 132 women were classified as sui i/ii, while 36 women were classified as sui iii.For retropubic slings, the gynecare tvt exact system was applied using the bottom-to-top route.Cystoscopy was performed during the operation to detect possible bladder perforation.For transobturator slings, the gynecare tvt obturator system was applied using the medial-to-lateral route.No cystoscopy was performed when choosing the transobturator method.Reported complication: transient voiding dysfunction (n-4).Stress urinary incontinence (n- 5).Persistent voiding dysfunction (n- 2).Tape erosion (n-2).In conclusion, this study highlights that lower mucp and higher bmi are significant predictors of sui severity that can potentially be used to guide future prevention and treatment strategies.Tvt is a safe procedure with a high success rate, even in women with severe sui.Further studies are needed to validate these findings.These should preferably include randomized control trials with control groups and a longer follow-up period.

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.An attempt has been 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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.Citation: journey of clinical medicine.Https://doi.Org/10.3390/jcm12165422.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT 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: 18876895
• MDR Text Key: 337347423
• Report Number: 2210968-2024-02824
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention