PREMIUM HEEL GUARD 6145

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-10 for PREMIUM HEEL GUARD 6145 manufactured by J. T. Posey Co..

Event Text Entries

[5479663] Customer reported the pt had a bilateral breakdown on the outside of the foot and a small deep tissue injury (dti).
Patient Sequence No: 1, Text Type: D, B5


[5656097] Supplemental based on no product return evaluation.
Patient Sequence No: 1, Text Type: D, B5


[13051862] 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).
Patient Sequence No: 1, Text Type: N, H10


[13109081] 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 bilateral 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2020362-2015-00033
MDR Report Key4589027
Report Source06
Date Received2015-03-10
Date of Report2015-03-19
Date of Event2015-01-01
Date Mfgr Received2015-03-19
Date Added to Maude2015-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSOKEA PEOU
Manufacturer Street5635 PECK RD.
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREMIUM HEEL GUARD
Generic NamePROTECTOR, SKIN PRESSURE
Product CodeFMP
Date Received2015-03-10
Model Number6145
Catalog Number6145
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerJ. T. POSEY CO.
Manufacturer AddressARCADIA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.