PILLOW, GENTLETOUCH, 7 INCH RT

Additional Manufacturer Narrative

BASED ON THE INFORMATION OBTAINED FROM THE INVESTIGATION, THE PATIENT WAS POSITIONED PRONE ON THE PILLOW FOR MORE THAN 8 HOURS THAT LED TO THE TISSUE INJURY. IT IS DEEMED AS AN USER ERROR AS THE INSTRUCTION FOR USE (IFU) INCLUDE SEVERAL WARNINGS SUCH AS: 1. FREQUENTLY MONITOR THE PATIENT'S NECK, HEAD, EYES, NOSE AND MOUTH TO ENSURE THAT A SAFE POSITION IS MAINTAINED, AND THE ET TUBE HAS NOT BEEN KINKED OR DISPLACED. FAILURE TO DO SO CAN LEAD TO SERIOUS ADVERSE CONSEQUENCES INCLUDING BLINDNESS, FAILURE TO VENTILATE, OR PRESSURE INJURIES TO THE FACE. 2. SOME ERYTHEMA MAY RESULT FROM SKIN CONTACT WITH THE MATERIALS IN THIS PRODUCT OR FROM COMPRESSION DURING PROLONGED CASES 3. NOT FOR CONTINUOUS USE OF MORE THAN 8 (EIGHT) HOURS THERE ARE NO REPORTED OR OBSERVED ISSUES WITH THE DEVICE. THIS CASE REPRESENTS THE ELEVATED RISK OF PRESSURE INJURIES DUE AN IMBALANCE BETWEEN THE WEIGHT OF THE PATIENT AND THE RECOMMENDED DURATION OF PROCEDURE/DEVICE USE. AS MENTIONED ABOVE, THE INSTRUCTIONS FOR USE (IFU) PROVIDES NECESSARY WARNINGS AND ALSO OPTIONS FOR FOR USERS TO BE INFORMED ON SELECTION OF PROPER PRE-OPERATIVE AND INTRA-OPERATIVE PROCEDURES. LIKEWISE, NATIONAL PRESSURE INJURY ADVISORY PANEL GUIDELINES POINT TO SIMILAR PREVENTIVE MEASURES TO BE CONSIDERED WHILE POSITIONING THE PATIENT IN PRONE POSITION AND RECOGNIZING THE RISK FACTORS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEEP TISSUE INJURY ON FOREHEAD USING GENTLETOUCH PILLOW DURING 8+ HOUR PROCEDURE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEEP TISSUE INJURY ON FOREHEAD USING GENTLETOUCH PILLOW DURING 8+ HOUR PROCEDURE.