MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-07-27 for MILEX MX505 * manufactured by Coopersurgical, Inc..
[454709]
The product, milex uterine handy-vac system 6mm, plunger broke on aspiration. A 5mm device was 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. Usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2005-00018 |
| MDR Report Key | 720019 |
| Report Source | 06 |
| Date Received | 2005-07-27 |
| Date of Report | 2005-07-26 |
| Date Mfgr Received | 2005-06-27 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2006-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILEX |
| Generic Name | CANNULA CURETTE |
| Product Code | HHK |
| Date Received | 2005-07-27 |
| Model Number | MX505 |
| Catalog Number | * |
| Lot Number | 34987 |
| ID Number | * |
| Device Expiration Date | 2008-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 709088 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | * TRUMBULL CT * US |
| Baseline Brand Name | MILEX |
| Baseline Generic Name | CANNULA CORETTE |
| Baseline Model No | MX505 |
| Baseline Catalog No | MX505 |
| Baseline ID | MX505 |
| Baseline Device Family | CANNULA CORETTE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K760264 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-27 |