FDA Adverse Event
Injury
Summary report: N
MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
MDR report key: 1151465
·
Received September 5, 2008
Report
- Report Number
- 1811755-2008-00051
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- August 8, 2008
- Report Date
- September 5, 2008
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K040300
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RISK MANAGER AT THE HOSPITAL WOULD NOT RELEASE THE PRODUCT FOR INVESTIGATION. THE FAILURE CAN NOT BE CONFIRMED WITHOUT THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE USING A DRILL AND ATTACHMENT DURING A DENTAL PROCEDURE, A PT RECEIVED A BLISTER ABRASION ON THE MUCOSA SIDE OF THE MOUTH. VASELINE WAS APPLIED AT THE TIME OF THE INCIDENT AND NO FURTHER TREATMENT IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO DRILL MEDIUM STRAIGHT ATTACHMENT | CORE/MICRO POWER INSTRUMENTS AND ACCESSORIES | HBB | STRYKER INSTRUMENTS KALAMAZOO | 07240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |