FDA Adverse Event Malfunction Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 3000639 · Received March 12, 2013

Report

Report Number
9616091-2013-00432
Event Type
Malfunction
Date Received
March 12, 2013
Report Date
February 14, 2013
Manufacturer
INVAMEX
Product Code
ILS
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES, THE SEAT IS CRACKED. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
102997 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9650-4

Patients

Seq Age Sex Outcome Treatment
1 Other