MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-06 for PAPETTE * manufactured by Wallach Surgical Devices, Inc..
[702911]
The md was performing a pap smear with a papette brush. As he was removing the device, the white brush tip came off of the handle and fell into the vaginal canal. The rn went to the ed to obtain a pair of forceps so that the md could remove the brush. The patient was not injured. The md is experienced in using this device & has not had this happen before. The brush was not forced into the cervical os and the md had no difficulty using the device. The md discarded the device; however, the bag from which this device came was checked. Of the six papettes remaining, one has a brush that is very loose and easily comes off. The other five papette brushes are securely fastened to the handles. The md was able to remove the brush from the vaginal canal and continue with the exam. The md and staff identified that the patient was obese, but believe that this was not a factor in this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 900476 |
| MDR Report Key | 900476 |
| Date Received | 2007-07-06 |
| Date of Report | 2007-07-06 |
| Date of Event | 2007-07-05 |
| Report Date | 2007-07-06 |
| Date Reported to FDA | 2007-07-06 |
| Date Added to Maude | 2007-08-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | PAPETTE |
| Generic Name | CELL COLLECTOR, CERVICAL |
| Product Code | HHT |
| Date Received | 2007-07-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 12X1 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 875946 |
| Manufacturer | WALLACH SURGICAL DEVICES, INC. |
| Manufacturer Address | 235 EDISON RD ORANGE CT 06477 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-06 |