FDA Adverse Event
Malfunction
Summary report: N
MONSEL'S 8ML
MDR report key: 887566
·
Received July 26, 2007
Report
- Report Number
- MW5003187
- Event Type
- Malfunction
- Date Received
- July 26, 2007
- Report Date
- July 26, 2007
- Manufacturer
- SKLAR INSTRUMENTS
- Product Code
- LMG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PRODUCT IS HARD/STICKY, NOT SMOOTH PASTE AS INTENDED. VERY DIFFICULT TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONSEL'S 8ML | NONE | LMG | SKLAR INSTRUMENTS | 579390 | ||
| 2 | MONSEL'S 8ML | NONE | LMG | SKLAR INSTRUMENTS | 579376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |