PREMIUM HEEL GUARD
Received Mar 5, 2015 · Event occurred Jan 1, 2015
Report 2020362-2015-00035 · MDR key 4573838
Device
Generic name
Protector, Skin Pressure
Manufacturer
J.t. Posey CompanyModel number
6145Catalog number
6145
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Erosion
Narrative
Description of Event or Problem
SUPPLEMENTAL SUBMISSION BASED ON NO PRODUCT RETURN EVALUATION.
Description of Event or Problem
CUSTOMER REPORTED THE PATIENT HAD A SKIN BREAKDOWN AND A SMALL DTI (DEEP TISSUE INJURY) AREA.
Additional Manufacturer Narrative
CONCLUSIONS: WITHOUT THE RETURN OF THE PRODUCT AND/OR IMAGES PROVIDED, THE COMPLAINT COULD NOT BE CONFIRMED. PER REPORT, THE HOSPITAL CHECKS ONCE EVERY SHIFT AT MINIMUM, WHICH DOES NOT MEET THE IFU SPECIFIED TO CHECK AT LEAST EVERY TWO HOURS. IT IS POSSIBLE THAT THIS CAUSED THE REPORTED ADDITIONAL OCCURRENCE WITH NO DETAILS. NOTE: ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT THIS TIME.
Additional Manufacturer Narrative
PRODUCT WAS REQUESTED TO BE RETURNED TO EVALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY'S REPORTED ISSUE. NOTE: POSEY INSTRUCTIONS FOR USE WARNS THE USER TO, "BE SURE TO FOLLOW YOUR FACILITY¿S POLICIES AND GUIDELINES FOR FREQUENCY OF PATIENT MONITORING. INSPECT THE PATIENT¿S LEG AT LEAST EVERY TWO HOURS TO CHECK FOR SKIN INTEGRITY, BLOOD CIRCULATION AND ADEQUATE ALLOWANCE FOR MOVEMENT OF LOWER LEG AND FOOT. INSPECT PRODUCTS BEFORE EACH USE: CHECK FOR BROKEN STITCHES; OR TORN, CUT OR FRAYED MATERIAL. DO NOT USE SOILED OR DAMAGED PRODUCTS. (B)(4).