FDA Adverse Event Injury Summary report: N

PERCUFLEX

MDR report key: 282033 · Received June 16, 2000

Report

Report Number
282033
Event Type
Injury
Date Received
June 16, 2000
Date of Event
May 23, 2000
Report Date
May 30, 2000
Manufacturer
MEDI-TECH, INC.
Product Code
FAD
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

RIGHT URETERAL STENT INSERTED IN 2000 FOR TREATMENT OF RENAL CALCULI. DISLODGED. RETURN TO SURGERY FOR REMOVAL/REPLACEMENT IN 2000. REPLACEMENT WITH 6X24 CM. STENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PERCUFLEX URETERAL STENT FAD MEDI-TECH, INC. 145-409 *

Patients

Seq Age Sex Outcome Treatment
1 21 YR Required Intervention