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 |