FDA Adverse Event Injury Summary report: N

TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

MDR report key: 9257740 · Received October 30, 2019

Report

Report Number: 2210968-2019-89256
Event Type: Injury
Date Received: October 30, 2019
Report Date: October 4, 2019
Manufacturer: ETHICON INC.
Product Code: OTN
PMA / PMN Number: K100936
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(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: NEUROUROLOGY AND URODYNAMICS. 2017;36:S77¿S78, DOI: 10.1002/NAU.23302 (JUNE 2017). (B)(4).

Description of Event or Problem · 1

TITLE: MID-URETHRAL SLING: IS A POSSIBLE AMBULATORY SURGERY? THIS CASE-CONTROL STUDY AIMED TO COMPARE IMMEDIATE VERSUS DELAYED CATHETER REMOVAL (CR) FOLLOWING TVT ABBREVO. FROM JANUARY 2014 TO JANUARY 2016, A TOTAL OF 38 WOMEN WITH IMMEDIATE CR FOLLOWING TVT ABBREVO FOR URODYNAMICALLY PROVEN STRESS INCONTINENCE (USI) WERE INCLUDED. EACH CASE WAS INDIVIDUALLY MATCHED WITH ONE CONTROL. COMPLAINT INCLUDED VOIDING DYSFUNCTIONS (POST-VOID RESIDUAL >100 ML) (N=2), POSTOPERATIVELY URINARY TRACT INFECTION (N=1), LATE ONSET OF OVERACTIVE BLADDER (OAB) (1YEAR) (N=2), AND VAGINAL EROSION (N=1). THE RESULTS IN THIS STUDY PRESENTED THAT TVT ABBREVO WITH IMMEDIATE CR IS A SAFE AND EFFICACY AMBULATORY PROCEDURE FOR TREATMENT OF FEMALE PURE STRESS URINARY INCONTINENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1050080	TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTN	ETHICON INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention