MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-04 for PAPETTE REF 908006 908006 manufactured by Wallach Surgical Devices, Inc..
[365083]
This device is used to collect ectocervical and endocervical cell samples from female pts. It looks like a small brush at the end of a stick-like handle. This brush component was retained in the pt's vagina until it was retrieved by the physician via bayonette forceps. Fortunately no injury was incurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032003 |
| MDR Report Key | 526252 |
| Date Received | 2004-05-04 |
| Date of Report | 2004-05-04 |
| Date of Event | 2004-04-28 |
| Date Added to Maude | 2004-05-25 |
| 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 | PAPETTE |
| Generic Name | CERVICAL BRUSH |
| Product Code | HFE |
| Date Received | 2004-05-04 |
| Model Number | REF 908006 |
| Catalog Number | 908006 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515406 |
| Manufacturer | WALLACH SURGICAL DEVICES, INC. |
| Manufacturer Address | 235 EDISON ROAD ORANGE CT 06477 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-04 |