MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-12 for VAGINAL - CERVICAL - AHLUWALIA'S RETRACTOR - ELEVATOR 60-6085-100 manufactured by Con Med.
[2367457]
While using uterine manipulator - disposable - on the patient, it broke into a few pieces. All pieces were removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023453 |
| MDR Report Key | 2379406 |
| Date Received | 2011-12-12 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-12-01 |
| Date Added to Maude | 2011-12-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAGINAL - CERVICAL - AHLUWALIA'S RETRACTOR - ELEVATOR |
| Generic Name | VAGINAL - CERVICAL - AHLUWALIA'S RETRACTOR - ELEVATOR |
| Product Code | HDP |
| Date Received | 2011-12-12 |
| Model Number | 60-6085-100 |
| Catalog Number | 60-6085-100 |
| Lot Number | 1109192 |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CON MED |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502599 US 13502 5994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-12 |