FDA Adverse Event Injury Summary report: N

URETEX SUP URETHRAL SUPPORT SYSTEM

MDR report key: 3172311 · Received April 24, 2013

Report

Report Number
1018233-2013-01537
Event Type
Injury
Date Received
April 24, 2013
Report Date
September 26, 2018
Manufacturer
C.R. BARD, INC. (COVINGTON) -1018233
Product Code
OTN
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
NY, US
Reporter Occupation
ATTORNEY
Health Professional
N

Narratives

Description of Event or Problem · 1

IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY, AND IMPAIRMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
177929 URETEX SUP URETHRAL SUPPORT SYSTEM No Match OTN C.R. BARD, INC. (COVINGTON) -1018233 NA C24146SUP

Patients

Seq Age Sex Outcome Treatment
1 Female Required Intervention MARLEX MESH