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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Date 03/17/2022

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-02827.Citation: doi 10.7759/cureus.23278 please see article attached.

Event Description

Title: comparison of autologous rectus fascia and synthetic sling methods of transobturator mid- urethral sling in urinary stress incontinence the aim of the study is to compare the efficacy and complications between mesh obtained from the autologous rectus fascia and synthetic mesh used in transobturator tape procedure in the surgical treatment of urinary stress incontinence.A total of 62 female patients who underwent an operation for sui between (b)(6) 2014 and (b)(6) 2017 were included in the study.31 patients underwent autologous rectus fascia with mid-urethral sling (group 1), and the remaining 31 patients underwent the same operation using synthetic multilaminar propylene sling (group 2).In group 1 patients, during the procedure, the skin was subcutaneously sutured.Lateral attachments were created on the short edges of the fascia with 1-0 vicryl (ethicon).In group 2, 31 patients were applied the same procedure using synthetic multilaminar propylene sling material (tvt obturator system - ethicon-gynecare, oh, usa).Reported complications are hemorrhage, urinary retention, hematoma, mesh erosion, wound infection, urinary infection, urethra injury, bladder injury, late-period pain and dyspareunia.In conclusion, transobturator tape procedure with autologous rectus fascia is as effective and safe as synthetic mesh.This procedure provides an inexpensive and consumable option without posing a risk of mesh erosion and with low complication rates.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18877071
• MDR Text Key: 337350959
• Report Number: 2210968-2024-02828
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K033568
• 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: 03/11/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other