GENERAL PURPOSE PROBE, 400 SERIES9 FR/APP29"L/1/2"DIA

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "PATIENT SUFFERED A SKIN INJURY OF THE LEFT BUTTOCKS 5 INCHES LONG 1/2 CENTIMETER WIDE STAGE 2 SKIN INJURY" FOLLOW-UP INFORMATION CONFIRMED IT WAS A PRESSURE INJURY. DEROYAL INDUSTRIES REQUESTED RETURN OF THE PRODUCT, HOWEVER, IT WAS NOTED THAT THE PRODUCT WAS DISCARDED AND NOT AVAILABLE FOR RETURN. DEROYAL REVIEWED FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) RELATED TO THIS ISSUE, AND NO ISSUES WERE FOUND. BECAUSE NO LOT NUMBER WAS PROVIDED WITH THE REPORT, NO SPECIFIC DESIGN HISTORY RECORD COULD BE REVIEWED, HOWEVER, MATERIAL REVIEW REPORT (MRRS) AND 125 GENERAL PURPOSE PROBES IN INVENTORY WERE INSPECTED. NO ISSUES WERE FOUND. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE 0.02%. ROOT CAUSE: BECAUSE THE PRODUCT WAS NOT RETURNED, NO LOT NUMBER WAS PROVIDED, AND ALL PRODUCTION RECORDS WERE FOUND TO HAVE NO ISSUES, NO ROOT CAUSE WAS ABLE TO BE ESTABLISHED. POTENTIAL ROOT CAUSE: WHILE NO SPECIFIC ROOT CAUSE COULD BE DETERMINED, BASED ON THE PRESSURE INJURY DESCRIBED, IT IS POSSIBLE THE PATIENT WAS POSITIONED ON THE GENERAL PURPOSE PROBE FOR TOO LONG WITHOUT ROTATION OR MOVEMENT. CORRECTIVE AND PREVENTIVE ACTION: BECAUSE NO ROOT CAUSE WAS ABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS HAVE BEEN TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED, "PATIENT SUFFERED A SKIN INJURY OF THE LEFT BUTTOCKS 5 INCHES LONG 1/2 CENTIMETER WIDE STAGE 2 SKIN INJURY".