FDA Adverse Event
Malfunction
Summary report: N
STRYKER
MDR report key: 7556537
·
Received May 30, 2018
Report
- Report Number
- MW5077543
- Event Type
- Malfunction
- Date Received
- May 30, 2018
- Date of Event
- May 22, 2018
- Report Date
- May 25, 2018
- Manufacturer
- STRYKER
- Product Code
- JEW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SMALL TIP OF PICK BROKE OFF IN PT DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394120 | STRYKER | DENTAL PICK | JEW | STRYKER | 700151 | X00272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |