WEDGE,FOAM,30 DEGREE,COVERED,NONSLIP,6PR

Description of Event or Problem

ACCORDING TO THE FACILITY "DURING THE TRIAL PERIOD" THE PATIENT EXPERIENCED A STAGE II PRESSURE INJURY DESCRIBED AS "PINK WOUND BED WITH SMALL AREA OF DARKER DISCOLORATION" IN RELATION TO USING A 30-DEGREE NONSLIP FOAM WEDGE.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY "DURING THE TRIAL PERIOD" THE PATIENT EXPERIENCED A STAGE II PRESSURE INJURY DESCRIBED AS "PINK WOUND BED WITH SMALL AREA OF DARKER DISCOLORATION" IN RELATION TO USING A 30-DEGREE NONSLIP FOAM WEDGE. PER THE FACILITY THE PRESSURE INJURY "WAS NOT PRESENT ON ADMISSION WHEN THE SKIN ASSESSMENT WAS PERFORMED". PER THE FACILITY "VENELEX OINTMENT WAS ORDERED AT DISCOVERY, THEN TRIAD CREAM LATER TO HEAL AND PROTECT FROM INCONTINENCE". PER THE FACILITY SKIN CHECKS ARE PERFORMED "EVERY SHIFT AND AS NEEDED" AND THE PATIENT IS TURNED "EVERY 2 HOURS FOR LEFT AND RIGHT ONLY AND NEVER SUPINE WHILE IN BED". PER THE FACILITY THE PATIENT HAD A DOCUMENTED BRADEN SCALE OF 10 ON THE DATE OF THE INJURY AND WAS ON VASOPRESSORS DURING THEIR STAY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE RELATED TO THE REPORTED INCIDENT. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.