MCKESSON BRANDS
Received Apr 8, 2026 · Event occurred Nov 24, 2025
Report 3015337348-2026-00001 · MDR key 24813881
Device
Generic name
Staple Remover Tray, Skin W/prep,
Manufacturer
Primecare Medical (suzhou) Co.,ltd.Catalog number
241
Lot number
CZE06-02
Product problems
- Difficult to Remove
Patient
NA · Unknown
- Skin Tears
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER HAS CONDUCTED APPEARANCE TEST AND PERFORMANCE TESTING ON THE RETURNED SAMPLE, AND THE TEST RESULTS ARE QUALIFIED; NO PHENOMENON DESCRIBED IN THE REPORT WAS FOUND DURING SIMULATED USE. IN ADDITION, THE MANUFACTURER RANDOMLY SELECTED 5 SAMPLES FROM THE RETAINED SAMPLES OF THE SAME LOT FOR TESTING, AND THESE SAMPLES ALSO PASSED THE TESTS. DHR FOR PRODUCT CZE06-02 WAS REVIEWED. NO DEVIATIONS WERE IDENTIFIED DURING THE PRODUCTION PROCESS, INCLUDING IN-PROCESS AND FINISHED PRODUCT INSPECTIONS. ALL PRODUCT INSPECTIONS WERE FOUND ACCEPTABLE. THIS PRODUCT IS FOR PRESCRIPTION USE ONLY, AND THE EVENT LOCATION IS HOME, WHICH IS EXPECTED TO BE CAUSED BY INCORRECT USE METHODS.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN ATTEMPTING TO REMOVE STAPLE, THE PLIERS CRIMPED THE STAPLE AND PUSHED IT DOWNWARD INTO THE SKIN INSTEAD OF LIFTING IT OUTWARD. PATIENT DID HAVE TO GO INTO SURGEON'S OFFICE TO GET THE STAPLES REMOVED AFTER THEY BECAME BOWED AND REMAINED IN THE SKIN.