PURITAN HISTOBRUSH
Received Jun 30, 2016 · Event occurred May 31, 2016
Report 1216735-2016-00003 · MDR key 5762513
Device
Generic name
Cytology Brush
Manufacturer
Puritan Medical Products Company LlcModel number
2199Catalog number
2199
Lot number
83150
Product problems
- Device Issue
- Device Issue
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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.