FDA Adverse Event
Malfunction
Summary report: N
MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
MDR report key: 2200899
·
Received July 1, 2011
Report
- Report Number
- 1811755-2011-02378
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 7, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT FOR ANALYSIS BECAUSE A RED RESIDUE WAS COMING OUT OF THE DEVICE DURING CLEANING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO DRILL MEDIUM STRAIGHT ATTACHMENT | ERL | STRYKER INSTRUMENTS KALAMAZOO | 10147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |