MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-01 for PAPETTE REF 908006 * manufactured by Wallach Surgical Devices, Inc..
[282407]
Pap test routine, no uti or vaginal yeast infections last 3 years. Evening after pap 1) internal discomfort, 2) a. M. Painful lesions - slight bleeding, swelling, discoloration, 3) peeling, 4) swollen lymph nodes with flu like symptoms, 5) yeast infection, 6) uti cultured and treated, 7) yeast infection, 8) continued discharge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028041 |
| MDR Report Key | 451801 |
| Date Received | 2003-04-01 |
| Date of Report | 2003-03-27 |
| Date of Event | 2003-02-11 |
| Date Added to Maude | 2003-04-08 |
| 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 | 0 |
| 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 | PAPETTE |
| Generic Name | CERVICAL CELL COLLECTOR |
| Product Code | HHT |
| Date Received | 2003-04-01 |
| Model Number | REF 908006 |
| Catalog Number | * |
| Lot Number | 10U1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 440798 |
| Manufacturer | WALLACH SURGICAL DEVICES, INC. |
| Manufacturer Address | 235 EDISON ROAD ORANGE CT 06477 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-04-01 |