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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/28/2020

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.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-02673, 2210968-2024-02674 and 2210968-2024-02675.Citation: ultrasound obstet gynecol 2023 doi: 10.1002/uog.26142.Https://pubmed.Ncbi.Nlm.Nih.Gov/36508434/.

Event Description

Title - association between sonographic sling location and success of surgery for stress urinary incontinence.The aim of this study is to determine the relationship between the clinical outcome of suburethral sling surgery for stress urinary incontinence and sling location on ultrasound examination.This was a retrospective study of 378 patients diagnosed with stress urinary incontinence who were treated with a suburethral sling by a single surgeon between january 2009 and october 2016 was included in this study.Of the 248 (65.6%) women treated with inside-out transobturator slings, 121 were fitted with tension-free vaginal tape (tvt¿) obturator (ethicon) and 127 with tvt abbrevo (ethicon).Of the 96 (25.4%) women treated with retropubic slings, 63 received tvt exact (ethicon) and 33 received advantage fit¿ (boston scientific - competitor) and further 34 (9.0%) women received other types of slings.Reported complication: persistent sui (n-19).Leakage (n-40).Conclusion a shorter spg on transperineal ultrasound imaging after suburethral sling surgery is associated with cure of stress urinary incontinence.

• 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: 18860754
• MDR Text Key: 337181206
• Report Number: 2210968-2024-02675
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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

• Date FDA Received: 03/07/2024
• 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: 02/20/2024
• 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