FDA Adverse Event
Malfunction
Summary report: N
IMMERSION HYDROBATH
MDR report key: 3963936
·
Received July 29, 2014
Report
- Report Number
- 1219590-2014-00112
- Event Type
- Malfunction
- Date Received
- July 29, 2014
- Report Date
- June 24, 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
Description of Event or Problem · 1
CUSTOMER STATES THE DOOR SEAL IS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440915 | IMMERSION HYDROBATH | 890.5100 | ILJ | INVACARE CLEVELAND STREET | IH3650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |