FDA Adverse Event
Malfunction
Summary report: N
IMMERSION HYDROBATH
MDR report key: 3734093
·
Received April 8, 2014
Report
- Report Number
- 1219590-2014-00061
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Report Date
- March 10, 2014
- Manufacturer
- INVACARE CLEVELAND STREET
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SEAL ON A TUB WAS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211163 | IMMERSION HYDROBATH | 890.5100 | ILJ | INVACARE CLEVELAND STREET | IH3650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |