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

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

Patient Problems Cyst(s) (1800); Hematoma (1884); Perforation of Vessels (2135)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported in a journal article with title: retropubic midurethral slings: does trocar size matter? the objective of this study is to compare the safety and peri-operative morbidity of three commercially available midurethral slings, differing in introducer dimensions and characteristics, in women who underwent a retropubic midurethral sling (mus) procedure.Between 2014 and 2021, 330 female patients underwent a retropubic mus procedure using a tension-free vaginal tape ((tvt) 5.0 mm diameter trocar containing polypropylene mesh) [gynecare]).(n=33) cystotomy.Patient quantity not indicated for these complications: vascular injury pelvic hematoma failed retrograde trial of void.Results of this study suggest that type of mus device is not associated with frequency of cystotomy, vascular injury, urethral injury, or pelvic hematoma and does not affect ebl or operative time.

Manufacturer Narrative

Product complaint # (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.  citation: american journal of obstetrics and gynecology.2022 mar; conference: society of gynecologic surgeons 48th annual scientific meeting.San antonio united states.226(3 supplement) :s1330.If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: TENSION FREE VAGINAL TAPE 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
• MDR Report Key: 14256770
• MDR Text Key: 290446415
• Report Number: 2210968-2022-03176
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2023
• 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): Other
• Patient Sex: Female