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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Unspecified Tissue Injury (4559)

Event Date 07/20/2023

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.Citation: international urogynecology journal vol 34:2767¿2774.Https://doi.Org/10.1007/s00192-023-05600-7.

Event Description

Title : impact on urinary incontinence after management of complications related to a retropubic midureteral sling.The main aim of this study was to evaluate the frequency of complications with regard to the mus procedure with a specific focus on pour and vaginal exposure, the treatment of these complications, and the potential impact on the efficacy of the mus procedure.A review of the medical records of women undergoing mus procedures from 1 january 2017 to 31 december 2021 (n = 329).The only mus system used at the department is the tvt exact.The reported complications included bladder perforations (n=5), infections (n=16), hematoma (n=3), pain (n=6), exposure to vaginal mucosa (n=8),persistent stress urinary incontinence (n=3), postoperative urinary retention >24 h (n=23)and de novo urgency (n=10).In conclusion, mobilization of the mus must be considered the optimal treatment for pour when cisc fails.It is the most effective intervention with the best effect on pour and the lowest risk of incontinence.Concerning vaginal exposure, a trial of recovering should be attempted as the risk of incontinence when undergoing a partial removal of the mus is considerable.

• 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: 18807621
• MDR Text Key: 336562842
• Report Number: 2210968-2024-02133
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 02/29/2024
• 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