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); Hematoma (1884); Pain (1994); Pocket Erosion (2013); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Date 08/09/2022

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.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: the journal of urology.Https://doi.Org/10.1097/ju.0000000000002720.

Event Description

Title: tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year followup from a randomized clinical trial.The aim of this study is to determine whether polyacrylamide hydrogel (pahg) is noninferior to tension-free vaginal tape (tvt) in the treatment of women with primary stress urinary incontinence (sui).Primary sui patients referred from primary health care and eligible for tvt operation between (b)(6) 2015 and (b)(6) 2017 are included in this study.This noninferiority trial, 223 women eligible for operative sui treatment were randomized for tvt (110) or pahg (113).All procedures were done in an outpatient setting.As a mid urethral sling tvt (tvt-exact- ethicon) also, pahg injections (bulkamid ¿ competitor) were performed under local anesthesia using periurethral lidocaine (10 ml) injections.Reported complication: hematoma (n-6), bladder perforation (n-6), accute urinary retention (n-10), pain (n-6), dysuria (n- 4), vaginal tape extrusion (n-3), and urinary tract infection (n-7).Conclusions: in midterm followup, pahg did not reach in patient satisfaction the noninferiority set in our study.Furthermore, mid urethral tvt slings show better subjective and objective cure rates than pahg.However, complications were more often associated with tvt.Since the majority of pahg treated women were also cured or improved, primary sui women can be offered pahg as a safe and durable alternative treatment.

• 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: 18878105
• MDR Text Key: 337404252
• Report Number: 2210968-2024-02835
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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