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

Catalog Number TVTEXAUNK

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

Patient Problems Hematoma (1884); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (tension-free vaginal tape- exact ) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (tension-free vaginal tape- exact ) involved? citation: monash health ics.2017: s199.(b)(4).

Event Description

It was reported in a journal article with tile: long term voiding function following retropubic sling the retropubic midurethral sling (rmus) described by ulmsten has become the gold standard for the treatment of stress urinary incontinence since 1996.The objective and subjective outcomes related to urine flow of patients who had a retropubic sling for more than five years will give us a better understanding of the impact of retropubic slings and we will be able to advice better regarding operation¿s long term implications.A total of 84 patients who had a retropubic sling inserted before august 2011 were eligible to participate in the study.Of which, 75 patients (mean age: 70 ± 10 years) underwent tvt exact retropubic slings (ethicon).Reported complications included bladder perforations that were corrected intraoperatively and retropubic hematoma that was managed conservatively.Retropubic midurethral slings may affect urine flow and voiding function in the long term.Maximum flow rate is significantly lower and post void residuals are significantly higher but this may not be clinically significant.Subjective and objective cure rates for sui seem to decrease over time but patient global impression for symptoms remains high.

• Brand Name: TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9258277
• MDR Text Key: 167331718
• Report Number: 2210968-2019-89266
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2019

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
• Device Catalogue Number: TVTEXAUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/30/2019
• 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