MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-19 for PAP SMEAR KIT UNK manufactured by Unk.
[465918]
Obgyn did a clinical study on a pt. Md used a cyto broom and did 3 pap smears on a pt. Two days later, pt started having cramps and pains. Pt went to er because she was bleeding. Had a miscarriage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036648 |
| MDR Report Key | 734611 |
| Date Received | 2005-09-19 |
| Date of Report | 2005-09-19 |
| Date of Event | 2005-08-26 |
| Date Added to Maude | 2006-07-18 |
| 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 | PATIENT |
| 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 | PAP SMEAR KIT |
| Generic Name | CYTOBROOM |
| Product Code | HHT |
| Date Received | 2005-09-19 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 722499 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2005-09-19 |