FDA Adverse Event Malfunction Summary report: N

ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754

MDR report key: 4664644 · Received April 7, 2015

Report

Report Number
9616091-2015-00985
Event Type
Malfunction
Date Received
April 7, 2015
Report Date
March 17, 2015
Manufacturer
INVAMEX
Product Code
ILS
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). DLR STATES THAT HE SOLD 3 CASES OF THE 9650-4 ALUMINUM COMMODES AND THE USER STATES THAT THE SEAT COMES OFF ALL THE TIME. REPLACING P/N 1112182 SEAT WITH LID. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
228220 ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754 ADAPTOR, HYGIENE ILS INVAMEX 9650-4

Patients

Seq Age Sex Outcome Treatment
1 Other