MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-15 for KLEEN VAGINAL SPECULUM * 40755-025 manufactured by Cardinal Health Corp.
[402356]
At completion of a pap smear the speculm could not be closed to promote removal from the vagina. The device had to be dismantled. Pt had a small amount of bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034964 |
| MDR Report Key | 584102 |
| Date Received | 2005-03-15 |
| Date of Report | 2005-03-15 |
| Date of Event | 2005-02-15 |
| Date Added to Maude | 2005-03-24 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEEN VAGINAL SPECULUM |
| Generic Name | VAGINAL SPECULUM |
| Product Code | HDF |
| Date Received | 2005-03-15 |
| Model Number | * |
| Catalog Number | 40755-025 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 573928 |
| Manufacturer | CARDINAL HEALTH CORP |
| Manufacturer Address | 100 RARITAN CTR. PKWY P.O. BOX 3078 EDISON NJ 088183078 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-15 |