FDA Adverse Event
Injury
Summary report: N
MICROLET LANCETS
MDR report key: 1821202
·
Received August 27, 2010
Report
- Report Number
- 1826988-2010-00588
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 20, 2010
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- FMK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
LANCING DEVICES AND LANCETS ARE NOT SERIALIZED OR ASSIGNED LOT NUMBERS , SO IT IS NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE. LANCETS AND DEVICES ARE ALSO NOT (B)(4).
Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL ALLEGED SHE WAS SHOWING A PATIENT HOW TO USE HIS/HER BAYER METER AND LANCING DEVICE. WHILE DOING SO, SHE RECEIVED AN ACCIDENTAL NEEDLESTICK FROM A USED LANCET. NO OTHER INFORMATION WAS PROVIDED ABOUT THE EVENT. NO PRODUCT WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROLET LANCETS | FMK | BAYER HEALTHCARE, LLC | 6546P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |