MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-03 for UTERINE HANDYLOCKING SYSTEM * manufactured by Milex Products, Inc..
[427134]
The device is attached to a cannula to perform a d & e. After insertion of the cannula, the doctor applies gentle steady pressure to evacuate the product of conception. The hard plastic part of the plunger detached from the rubber stopper, causing the cannula to push further into the uterus. Four 60cc syringes failed the same day. They were being used by 2 attending physicians with many years experience. Only 1 syringe was saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 627124 |
| MDR Report Key | 627124 |
| Date Received | 2005-08-03 |
| Date of Report | 2005-08-03 |
| Date of Event | 2005-07-13 |
| Report Date | 2005-08-03 |
| Date Reported to FDA | 2005-08-03 |
| Date Added to Maude | 2005-08-17 |
| 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 | UTERINE HANDYLOCKING SYSTEM |
| Generic Name | SYRINGE |
| Product Code | HFC |
| Date Received | 2005-08-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 39608 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 616751 |
| Manufacturer | MILEX PRODUCTS, INC. |
| Manufacturer Address | 4311 N. NORMANDY CHICAGO IL 60634 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-03 |