FDA Adverse Event Malfunction Summary report: N

DAILY ACTIVITY ASSIST DEVICES

MDR report key: 3033904 · Received April 3, 2013

Report

Report Number
9616091-2013-00549
Event Type
Malfunction
Date Received
April 3, 2013
Date of Event
March 7, 2013
Report Date
March 7, 2013
Manufacturer
INVAMEX
Product Code
ILS
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SC, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES SEAT CRACKED IN TWO PLACES. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
136742 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

Patients

Seq Age Sex Outcome Treatment
1 Other