FDA Adverse Event
Malfunction
Summary report: N
ALL-IN-ONE COMMODE 9153629772
MDR report key: 4790125
·
Received May 22, 2015
Report
- Report Number
- 9616091-2015-01322
- Event Type
- Malfunction
- Date Received
- May 22, 2015
- Report Date
- April 29, 2015
- Manufacturer
- INVAMEX
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD MORE PERTINENT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
THE SEAT HAS A CRACK IN IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334692 | ALL-IN-ONE COMMODE 9153629772 | ADAPTOR, HYGIENE | ILS | INVAMEX | 9610-4 | 011414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |