MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-10 for MILEX UTERINE HANDY-VAC SYSTEM * manufactured by Milex Products.
[400403]
The product, milex uterine handy-vac system 6mm, plunger broke on aspiration. A 5mm device was then tried. The plunger broke with the 5mm. The doctor finished with a 7mm device. This device functioned correctly. Two weeks earlier, the same lot 5mm device failed to provide suction, nearly causing a uterine perforation. Five 5mm devices were tried. Three had similar problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 619809 |
| MDR Report Key | 619809 |
| Date Received | 2005-06-10 |
| Date of Report | 2005-06-10 |
| Date of Event | 2005-06-07 |
| Report Date | 2005-06-10 |
| Date Reported to FDA | 2005-06-10 |
| Date Added to Maude | 2005-07-08 |
| 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 | 3 |
| 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-VAC SYSTEM |
| Generic Name | ASPIRATION SYSTEM (CANNULA SYRINGE) |
| Product Code | HFC |
| Date Received | 2005-06-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 39487 5MM |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 609494 |
| Manufacturer | MILEX PRODUCTS |
| Manufacturer Address | 4311 N. NORMANDY CHICAGO IL 60634 US |
| Brand Name | UTERINE HANDYVAC |
| Generic Name | ASPIRATION SYSTEM (CANNULA SYRINGE) |
| Product Code | HFC |
| Date Received | 2005-06-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 39429 6MM |
| ID Number | * |
| Device Availability | N |
| Device Age | 2 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 609495 |
| Manufacturer | MILEX PRODUCTS INC. |
| Manufacturer Address | 4311 N NORMANDY CHICAGO IL 60634 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-10 |