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 Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Post Operative Wound Infection (2446)

Event Date 01/01/2007

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.Events related to tvt-o captured via 2210968-2021-03855 citation: obstetrics & gynecology vol.109, no.1, january 2007.Please see article attached.

Event Description

Title: retropubic compared with transobturator tape placement in treatment of urinary incontinence a randomized controlled trial.The present multicenter randomized clinical trial was initiated to compare the tvt procedure with the tvt-o procedure (both using the same polypropylene tape) in terms of intraoperative and immediate postoperative complications, cure rates, and health economic aspects.From march 2004 to november 2005, 273 female patients were randomly assigned to either the tvt or the tvt-o procedure using tvt and tvt-o kits (gynecare, ethicon, johnson & johnson, somerville, nj).136 in the tvt group and 131 in the tvt-o group.Tvt group: 2 patients postoperative groin pain.The groin pain of the tvt patients disappeared within 5¿10 days.1 patient needed two units of blood transfusion because of a retropubic hematoma 1 patient had an intraoperative bleeding of 800 ml, which was managed by drainage on the side of bleeding.1 patient experienced a wound infection.8% were postoperatively treated because of urinary tract infections.1 patient had urgency symptoms 3 patients had new symptoms of urgency postoperatively, either frequency or urgency, moderate or severe in their urogenital distress inventory, or a score greater than 7 in the detrusor instability score.Tvt-o group: 21 patients postoperative groin pain.The groin pain of the tvt-o patients persisted for 2 weeks in ten patients, for 4 weeks in three patients, and for 2 months in one patient, the rest having pain for a few days.13% were postoperatively treated because of urinary tract infections.1 patient had urgency symptoms 3 patients had new symptoms of urgency postoperatively, either frequency or urgency, moderate or severe in their urogenital distress inventory, or a score greater than 7 in the detrusor instability score.

• 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: 11740099
• MDR Text Key: 250952744
• Report Number: 2210968-2021-03857
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K974098
• 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: 04/01/2021

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: 04/01/2021
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1