MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-01 for MILEX CANNULA-CURETTE WITH 60 CC HANYVAK LOCKING SYRINGE * manufactured by Cooper Surgical.
[17258643]
The physician was using a mylex uterine handy vak 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 patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 631890 |
| MDR Report Key | 631890 |
| Date Received | 2005-08-01 |
| Date of Report | 2005-08-01 |
| Date of Event | 2005-07-16 |
| Report Date | 2005-08-01 |
| Date Reported to FDA | 2005-08-01 |
| Date Added to Maude | 2005-08-31 |
| 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 CANNULA-CURETTE WITH 60 CC HANYVAK LOCKING SYRINGE |
| Generic Name | CANNULA-CURETTE |
| Product Code | HFC |
| Date Received | 2005-08-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 39487 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 621472 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-01 |