FDA Adverse Event
Malfunction
Summary report: N
ALUMINUM CRUTCHES WITH ACCESSORIES
MDR report key: 1033802
·
Received April 22, 2008
Report
- Report Number
- 1033802
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- October 11, 2007
- Report Date
- April 1, 2008
- Manufacturer
- DRIVE MEDICAL DESIGN AND MFG
- Product Code
- IPR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
HOME MEDICAL EQUIPMENT DELIVERED CRUTCHES TO PATIENT IN HOSPITAL. HOME MEDICAL EQUIPMENT TECHNICIAN OPENED NEW PACKAGE IN PATIENT'S ROOM AND ADJUSTED THE CRUTCHES TO THE APPROPRIATE HEIGHT. WHEN PATIENT BEGAN TO BEAR WEIGHT ON CRUTCHES, THE PIN THAT LOCKS THE SLIDING BAR IN PLACE SLIPPED, AND THE CRUTCH COLLAPSED. PATIENT WAS UNHARMED. MANUFACTURER WAS NOTIFIED. THE WEIGHT OF THE PATIENT WAS NOT A FACTOR. THE CRUTCHES USED WERE APPROPRIATE FOR THE PATIENT'S WEIGHT. THERE HAS NOT BEEN ANY OTHER SIMILIAR EVENTS WITH THIS CRUTCH.====================== MANUFACTURER RESPONSE FOR CRUTCHES, ALUMINUM CRUTCHES WITH ACCESSORIES======================THEY SENT NEW CRUTCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINUM CRUTCHES WITH ACCESSORIES | CRUTCHES, PATIENT | IPR | DRIVE MEDICAL DESIGN AND MFG | * | 10400-8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |