MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-21 for PURITAN HISTOBRUSH 2199 manufactured by Puritan Medical Products Company Llc.
[47839356]
We have a 5-year market history of (b)(4) cytology devices per year. This is the first report of a brush failure. The production records and reserve samples from the lot were normal. This report is entered in our trend analysis program and will be monitored for similar claims.
Patient Sequence No: 1, Text Type: N, H10
[47839357]
The customer reports that the end of the cytology brush came off during a pap smear procedure. The doctor retrieved the brush.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216735-2016-00002 |
| MDR Report Key | 5738558 |
| Date Received | 2016-06-21 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-04-04 |
| Device Manufacturer Date | 2015-08-25 |
| Date Added to Maude | 2016-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR WILLIAM YOUNG |
| Manufacturer Street | 31 SCHOOL STREET PO BOX 149 |
| Manufacturer City | GUILFORD ME 044430149 |
| Manufacturer Country | US |
| Manufacturer Postal | 044430149 |
| Manufacturer Phone | 2078763311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURITAN HISTOBRUSH |
| Generic Name | CYTOLOGY BRUSH |
| Product Code | HHT |
| Date Received | 2016-06-21 |
| Model Number | 2199 |
| Catalog Number | 2199 |
| Lot Number | 18636 |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURITAN MEDICAL PRODUCTS COMPANY LLC |
| Manufacturer Address | 31 SCHOOL STREET PO BOX 149 GUILFORD ME 044430149 US 044430149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-21 |