COMFRTGL,W/BX,W/FB80X35X7,INTL 2850000012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-22 for COMFRTGL,W/BX,W/FB80X35X7,INTL 2850000012 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[136868331] It was reported that within a few hours, there was a decubitus ulcer development on the heel and ankle of a patient. Further information is not available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2019-00272
MDR Report Key8361286
Report SourceHEALTH PROFESSIONAL
Date Received2019-02-22
Date of Report2019-05-21
Date of Event2019-02-11
Date Mfgr Received2019-02-11
Device Manufacturer Date2018-06-01
Date Added to Maude2019-02-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN THOMPSON
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMFRTGL,W/BX,W/FB80X35X7,INTL
Generic NameMATTRESS, FLOTATION THERAPY, NON-POWERED
Product CodeIKY
Date Received2019-02-22
Catalog Number2850000012
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-22

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