FDA Adverse Event
Summary report: N
CRUTCH
MDR report key: 3013838
·
Received March 20, 2013
Report
- Report Number
- 1531186-2013-01175
- Date Received
- March 20, 2013
- Report Date
- February 22, 2013
- Manufacturer
- JAN MAO
- Product Code
- IPR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER STATES CUFF BROKE. HE HAD AN OLD MODEL WHICH OPENED AND ALLOWED HIM TO PUT CUFF OVER COAT. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115487 | CRUTCH | 890.3150 | IPR | JAN MAO | 8153-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 | Other |