DISPOSA-VIEW POSITIONER

Additional Manufacturer Narrative

DEROYAL INDUSTRIES REQUESTED THAT A SAMPLE BE RETURNED, BUT IT WAS NOT AVAILABLE TO BE RETURNED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER (B)(4). DEROYAL INDUSTRIES CHECKED INVENTORY FOR THE MATERIAL SUPPLIED BY (B)(4). THERE WERE (B)(4) PIECES INSPECTED AND NO ISSUES WERE FOUND. THE MANUFACTURING PROCESS WAS ALSO INSPECTED AND NO ISSUES WERE FOUND. A COMPLAINT TO SALES ANALYSIS WAS RUN AND FOUND TO BE (B)(4). UPON REVIEW OF LABELING, IT WAS NOTED THAT THE IFU STATES "CONFIRM THE HEAD POSITIONER IS PROPERLY FITTED TO THE PATIENTS FACE ACCESSING FOR ANY POTENTIAL PRESSURE POINTS. PERIODICALLY REASSESS THE PATIENTS POSITION IN THE HEAD POSITIONER FOR PRESSURE POINTS FACIAL CLEARANCE." ROOT CAUSE: BECAUSE NO SAMPLE WAS RETURNED AND NO ISSUES WERE ABLE TO BE DETERMINED FROM INVENTORY OR PRODUCTION PROCEDURES, THE ROOT CAUSE WAS DETERMINED TO BE UNKNOWN. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, NO CORRECTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUND THIS ISSUE AND ITEM. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A DISTRIBUTOR FACILITY REPORTED, "THERE ARE SIGNS OF DECUBITUS ON THE FACE AFTER PRONE-POSITION SURGERY. ACCORDING TO THE NEUROSURGEONS, THE DEVICE OFTEN CAUSES REDNESS ON THE MOST EXPOSED PARTS OF THE PATIENTS' FACE, WHICH THEN DEVELOPS INTO ABRASIONS AND PRESSURE INJURIES."

Additional Manufacturer Narrative

A DISTRIBUTOR FACILITY REPORTED, "THERE ARE SIGNS OF DECUBITUS ON THE FACE AFTER PRONE-POSITION SURGERY. ACCORDING TO THE NEUROSURGEONS, THE DEVICE OFTEN CAUSES REDNESS ON THE MOST EXPOSED PARTS OF THE PATIENTS' FACE, WHICH THEN DEVELOPS INTO ABRASIONS AND PRESSURE INJURIES." DEROYAL INDUSTRIES REQUESTED THAT A SAMPLE BE RETURNED, BUT IT WAS NOT AVAILABLE TO BE RETURNED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SUPPLIER (B)(4). THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.