FDA Adverse Event
Malfunction
Summary report: N
IMMERSION HYDROBATH
MDR report key: 3020117
·
Received March 25, 2013
Report
- Report Number
- 1525712-2013-02240
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Report Date
- February 28, 2013
- Manufacturer
- INVACARE TAYLOR 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
(B)(4). RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
PROVIDER STATES (B)(4) MIXING VALVE BROKEN SPRAYING WATER ALL OVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121791 | IMMERSION HYDROBATH | 890.5100 | ILJ | INVACARE TAYLOR STREET | IH3602GXL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |