MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-06-30 for PURITAN HISTOBRUSH 2199 manufactured by Puritan Medical Products Company Llc.
[48582323]
The incident original reporter could not verify the lot number provided. This report and our investigation was conducted based on the indefinite report lot number. Batch records did not reveal any anomalies. Similar product was tested and the defect could not be reproduced. We will continue to monitor reports of similar events.
Patient Sequence No: 1, Text Type: N, H10
[48582324]
Physician inserted the brush into the patient's cervix and after rotating it, the brush tip came out of the handle and remain in the patient's cervix. The physician was able to retrieve the brush readily. There is not any adverse events or injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216735-2016-00003 |
| MDR Report Key | 5762513 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2016-06-30 |
| 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 | 2016-06-30 |
| Model Number | 2199 |
| Catalog Number | 2199 |
| Lot Number | 83150 |
| 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 | 2016-06-30 |