PREMIUM HEEL GUARD
Received Mar 10, 2015 · Event occurred Jan 1, 2015
Report 2020362-2015-00034 · MDR key 4589043
Device
Generic name
Protector, Skin Pressure
Manufacturer
J. T. Posey Co.Model number
6145Catalog number
6145
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
ASKU
- Skin Erosion
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE PT HAD A BREAKDOWN ON THE OUTSIDE OF THE FOOT AND A SMALL DEEP TISSUE INJURY (DTI).
Additional Manufacturer Narrative
PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY'S REPORTED ISSUE. (B)(4).
Description of Event or Problem
SUPPLEMENTAL SUBMISSION BASED ON NO PRODUCT RETURN EVALUATION.
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 BREAKDOWN ON THE OUTSIDE OF THE FOOT AND SMALL DEEP TISSUE ISSUE. 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.