DEROYAL
Received Jan 29, 2013 · Event occurred Jan 8, 2013
Report 3004605321-2013-00001 · MDR key 2939276
Device
Product problems
- Material Protrusion/Extrusion
Patient
Not reported
- Laceration(s)
Narrative
Additional Manufacturer Narrative
DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BLADE WAS STICKING OUT FROM ONE OF THE BOTTOM FLAPS OF THE BOX. WHEN OPENED THE EMPLOYEE CONTACTED THE BLADE AND RECEIVED A LACERATION REQUIRING A TRIP TO THE HOSPITAL, 3 X-RAYS, A TETANUS SHOT, AND THREE STITCHES ON HER INDEX FINGER. DEROYAL: PICTURES OF THE DEFECT WERE RECEIVED FOR OUR INVESTIGATION. 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.
Description of Event or Problem
IT WAS REPORTED THAT A BLADE WAS STICKING OUT FROM ONE OF THE BOTTOM FLAPS OF THE BOX. WHEN OPENED THE EMPLOYEE CONTACTED THE BLADE AND RECEIVED A LACERATION REQUIRING A TRIP TO THE HOSPITAL, 3 X-RAYS, A TETANUS SHOT, AND THREE STITCHES ON HER INDEX FINGER.