FDA Adverse Event
Malfunction
Summary report: N
FREECURVE
MDR report key: 7397902
·
Received April 4, 2018
Report
- Report Number
- 3007802293-2018-00015
- Event Type
- Malfunction
- Date Received
- April 4, 2018
- Date of Event
- March 5, 2018
- Report Date
- April 4, 2018
- Manufacturer
- HANDICARE STAIRLIFTS B.V.
- Product Code
- PCD
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUTCOME OF INVESTIGATION IS PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem · 1
CUSTOMER REPORTED STAIRLIFT HAS ELECTRICAL SPARKS WHEN USED. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238191 | FREECURVE | FREECURVE | PCD | HANDICARE STAIRLIFTS B.V. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |