FDA Adverse Event Malfunction Summary report: N

ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE

MDR report key: 9716592 · Received February 17, 2020

Report

Report Number
1836161-2020-00010
Event Type
Malfunction
Date Received
February 17, 2020
Date of Event
January 23, 2020
Report Date
January 23, 2020
Manufacturer
ASPEN SURGICAL PRODUCTS, CALEDONIA
Product Code
FTA
PMA / PMN Number
K020304
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
181816 ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE LIGHT HANDLE FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-ALC01 202234

Patients

Seq Age Sex Outcome Treatment
1