UNKNOWN_MEDICAL_PRODUCT UNK_MED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[134091851] The user facility reported the patient developed a pressure ulcer.
Patient Sequence No: 1, Text Type: D, B5


[142463294] It was clarified that this injury was reported in error; it was confirmed with the customer that there was no adverse event associated with this device.
Patient Sequence No: 1, Text Type: N, H10


[142463295] The user facility reported the patient developed a pressure ulcer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2019-00007
MDR Report Key8275747
Date Received2019-01-24
Date of Report2019-04-17
Date of Event2018-12-19
Date Mfgr Received2019-01-14
Date Added to Maude2019-01-24
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. KRISTEN CANTER
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 Report0

Device Details

Brand NameUNKNOWN_MEDICAL_PRODUCT
Generic NameMATTRESS, FLOTATION THERAPY, NON-POWERED
Product CodeIKY
Date Received2019-01-24
Catalog NumberUNK_MED
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 2019-01-24

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