MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-04 for MILEX UTERINE HANDIVAK SYSTEM * 99070 manufactured by Milex Products, Inc.
[432691]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 645914 |
| MDR Report Key | 645914 |
| Date Received | 2005-11-04 |
| Date of Report | 2005-11-04 |
| Date of Event | 2005-11-02 |
| Report Date | 2005-11-04 |
| Date Reported to FDA | 2005-11-04 |
| Date Added to Maude | 2005-11-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILEX UTERINE HANDIVAK SYSTEM |
| Generic Name | SUCTION DEVICE FOR D E (DILITATION AND EXTRACTION) |
| Product Code | HFF |
| Date Received | 2005-11-04 |
| Model Number | * |
| Catalog Number | 99070 |
| Lot Number | 39487 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 635422 |
| Manufacturer | MILEX PRODUCTS, INC |
| Manufacturer Address | 4311 N. NORMANDY CHICAGO IL 60634 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-04 |