FDA Adverse Event
Summary report: N
MILEX UTERINE HANDIVAK SYSTEM
MDR report key: 645914
·
Received November 4, 2005
Report
- Report Number
- 645914
- Date Received
- November 4, 2005
- Date of Event
- November 2, 2005
- Report Date
- November 4, 2005
- Manufacturer
- MILEX PRODUCTS, INC
- Product Code
- HFF
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON PULLING BACK PLUNGER OF SYRINGE, THE PLUNGER PULLED BACK RAPIDLY AND PRODUCED NO SUCTION. DEVICE IS A MANUALLY OPERATED CANNULA WITH SUCTION PRODUCED BY PULLING BACK ON THE PLUNGER. THE DEVICE IS USED FOR D&ES (DILITATION AND EXTRACTION).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILEX UTERINE HANDIVAK SYSTEM | SUCTION DEVICE FOR D E (DILITATION AND EXTRACTION) | HFF | MILEX PRODUCTS, INC | * | 39487 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |