FDA Adverse Event
Malfunction
Summary report: N
DELRIN BUCKLE GAIT BELT
MDR report key: 21843
·
Received May 17, 1995
Report
- Report Number
- MW1005955
- Event Type
- Malfunction
- Date Received
- May 17, 1995
- Report Date
- April 24, 1995
- Manufacturer
- SKIL-CARE CORP.
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICAL THERAPIST
Narratives
Description of Event or Problem · 1
GAIT BELT WITH PLASTIC SNAP BUCKLE. REPORTS FROM PHYSICAL THERAPISTS OF DIFFICULTIES FASTENING BELT, CONCERNS REGARDING DURABILITY OF PLASTIC BUCKLE, DIFFICULTIES ADJUSTING FIT OF BELT ONCE CLIENT IN STANCE POSITION AND STILL MAINTAINING SUPPORT/SAFETY OF PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELRIN BUCKLE GAIT BELT | GAIT BELT | IKX | SKIL-CARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |