FDA Adverse Event
Malfunction
Summary report: N
SITZ BATH 1616700692
MDR report key: 4919709
·
Received July 16, 2015
Report
- Report Number
- 1219590-2015-00112
- Event Type
- Malfunction
- Date Received
- July 16, 2015
- Report Date
- June 23, 2015
- Manufacturer
- INVACARE CLEVELAND STREET
- Product Code
- KTC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
DOOR SEAL LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462163 | SITZ BATH 1616700692 | BATH, SITZ, NONPOWERED | KTC | INVACARE CLEVELAND STREET | IH3800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |