FDA Adverse Event
Malfunction
Summary report: N
IMMERSION HYDROBATH
MDR report key: 3729587
·
Received April 7, 2014
Report
- Report Number
- 1219590-2014-00060
- Event Type
- Malfunction
- Date Received
- April 7, 2014
- Report Date
- March 6, 2014
- Manufacturer
- INVACARE CLEVELAND STREET
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER PROVIDER, THE DOOR SEAL IS LEAKING ON THE TUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206753 | IMMERSION HYDROBATH | 890.5100 | ILJ | INVACARE CLEVELAND STREET | IH3652G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |