MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-10-03 for MILEX MX505 * manufactured by Coopersurgical, Inc..
[463736]
The physician was using a milex uterine handyvak system which includes a 60cc syringe and a cannula. The cannula was successfully inserted through the cervix. On gently pulling back, the hard plastic part of the plunger disengaged from the rubber stopper. On sudden disconnection, the cannula went slightly deeper into the uterus. There was no pt injury. Device usage problem: device failed (e. G. Broke, couldn't get to work or stopped working). Device usage problem: device malfunction - that is, the device did not do what it was supposed to do. Reference medwatch 2200310000-2005-8033.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2005-00026 |
| MDR Report Key | 698968 |
| Report Source | 00 |
| Date Received | 2005-10-03 |
| Date of Report | 2005-09-30 |
| Date Mfgr Received | 2005-09-13 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2006-04-14 |
| 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 | 2005-10-03 |
| Model Number | MX505 |
| Catalog Number | * |
| Lot Number | 39487 |
| ID Number | * |
| Device Expiration Date | 2008-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 688054 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 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 | 1. Required No Informationntervention | 2005-10-03 |