FDA Adverse Event
Injury
Summary report: N
COMMAND MICROELECTIVE KAVOL 1:1 REDUCTION HEAD
MDR report key: 35658
·
Received August 16, 1996
Report
- Report Number
- MW1009726
- Event Type
- Injury
- Date Received
- August 16, 1996
- Date of Event
- January 1, 1996
- Report Date
- August 7, 1996
- Manufacturer
- STRYKER CORP.
- Product Code
- DZI
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
INITIAL SYMPTOMS WERE RESPIRATORY BUT DIAGNOSIS NOT MADE FOR OVER 1 YEAR. PHYSICIAN THOUGHT IT WAS NON-OCCUPATIONAL (FALL '94 THROUGH 1/96). RESPIRATORY PROBLEMS WORSENED AND LATER BODY RASH APPEARED. 12/95 LATEX RAST TEST - TOTAL RESULTS 1/96. 1/96 - HISTAMINE RELEASE BLOOD TESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMMAND MICROELECTIVE KAVOL 1:1 REDUCTION HEAD | DENTAL DRILL | DZI | STRYKER CORP. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| S | ||
| 2 | ||||
| 3 |