MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-13 for MILEX UTERINE HANDY VAK SYSTEM * 99070 manufactured by Milex Products, Inc..
[422761]
The device is a hand operated syringe with a cannula for performing d&e, dilation and evacuation. After the cannula is introduced into the uterus, suction is applied by pulling back on the plunger handle while holding the syringe barrel steady in the uterus. On initiating suction, the handle pulled away from the rubber stopper of the plunger. The counter pressure on the barrel caused the cannula to be pushed further into the uterus. The patient was not harmed because the doctor prevented the cannula from pushing through the uterine wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 621760 |
| MDR Report Key | 621760 |
| Date Received | 2005-07-13 |
| Date of Report | 2005-07-13 |
| Date of Event | 2005-07-01 |
| Report Date | 2005-07-13 |
| Date Reported to FDA | 2005-07-13 |
| Date Added to Maude | 2005-07-20 |
| 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 | 3 |
| 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 HANDY VAK SYSTEM |
| Generic Name | ASPIRATION CANNULA |
| Product Code | HFC |
| Date Received | 2005-07-13 |
| Model Number | * |
| Catalog Number | 99070 |
| Lot Number | 39429 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 611408 |
| Manufacturer | MILEX PRODUCTS, INC. |
| Manufacturer Address | 4311 N. NORMANDY CHICAGO IL 606341403 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-13 |