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Received Jan 24, 2007 · Event occurred Sep 15, 2006
Report 1216677-2006-00019 · MDR key 818498
Device
Generic name
Endocervical Sampler
Manufacturer
Coopersurgical, Inc.Model number
C0004Catalog number
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Lot number
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Product problems
- Detachment Of Device Component
Patient
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- Foreign body, removal of
Narrative
Description of Event or Problem
DURING AN STD EXAM, THE BRUSH HEAD CAME APART FROM THE HANDLE. FORCEPS WERE USED TO REMOVE THE BRUSH HEAD.
Additional Manufacturer Narrative
THE USER FACILITY PURCHASES THE PRODUCT THROUGH A DISTRIBUTOR. THE USER FACILITY OPENS THE PACKAGES AND STOCKS EACH EXAMINING ROOM. IN SO DOING, LOT NUMBER IDENTIFICATION IS NOT POSSIBLE. THE SAMPLE PROVIDED BY THE INITIAL REPORTER WAS COMPARED TO PRODUCT ON HAND. THE SAMPLE PROVIDED BY THE INITIAL REPORTER HAD A DIFFERENT COLORED HANDLE AND LACKED THE RED IN-LINE PRINTING. THE SAMPLE WAS CONFIRMED TO BE NOT PRODUCED BY COOPERSURGICAL.