FDA Adverse Event
Malfunction
Summary report: N
SITZ BATH 1616700692
MDR report key: 4897908
·
Received July 8, 2015
Report
- Report Number
- 1219590-2015-00105
- Event Type
- Malfunction
- Date Received
- July 8, 2015
- Report Date
- June 12, 2015
- Manufacturer
- INVACARE CLEVELAND STREET
- Product Code
- KTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
DOOR SEAL LEAKING, NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442406 | SITZ BATH 1616700692 | BATH, SITZ, NONPOWERED | KTC | INVACARE CLEVELAND STREET | IH3652G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |