DEROYAL
Received Feb 12, 2013 · Event occurred Jan 17, 2013
Report 3004605321-2013-00002 · MDR key 2974233
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BLADE STUCK THROUGH THE BOTTOM OF THE BOX CAUSING A MINOR CUT THAT DID NOT REQUIRE MEDICAL ATTENTION. THIS WAS A FIRST AID CASE ONLY.
Additional Manufacturer Narrative
(B)(4): THIS DEFECT WAS DETERMINED TO BE AN ISOLATED EVENT. INTERNAL INSPECTIONS WERE PERFORMED DURING THE RELABELING PROCESS AND ON FINISHED GOODS WHERE NO DEFECTS WERE FOUND. AS A CORRECTIVE ACTION ALL APPLICABLE PERSONNEL RECEIVED RETRAINING FOR HEIGHTENED AWARENESS WHEN PACKAGING THIS PRODUCT TO VERIFY THAT THE BLADES ARE NOT EXPOSED. THE PRODUCT IS UNDER 100% INSPECTION TO VERIFY ALL BLADES ARE RETRACTED PRIOR TO PACKAGING.