FDA Adverse Event
Malfunction
Summary report: N
BONE WAX
MDR report key: 15682
·
Received September 1, 1994
Report
- Report Number
- MW1003213
- Event Type
- Malfunction
- Date Received
- September 1, 1994
- Report Date
- August 24, 1994
- Manufacturer
- LUKENS MEDICAL CORP.
- Product Code
- MTJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
RPTR HAS BEEN FINDING PARTICLES OF SILVER ON THE BONE WAX USED AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE WAX | BONE WAX | MTJ | LUKENS MEDICAL CORP. | 057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |