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 2018-04-13 for UNKNOWN_MEDICAL_PRODUCT UNK_MED manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[105670280] It was reported that the patient was sitting on the edge of the unit and slid off. There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


[109412359] During the course of the investigation it was found that the mattress is not manufactured or distributed by stryker. Device not manufactured by stryker.
Patient Sequence No: 1, Text Type: N, H10


[109412360] It was reported that the patient was sitting on the edge of the unit and slid off. There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2018-00200
MDR Report Key7430868
Date Received2018-04-13
Date of Report2018-05-21
Date of Event2018-02-27
Date Mfgr Received2018-03-16
Date Added to Maude2018-04-13
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. CHANDA BURGHARD
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 NameBED, FLOTATION THERAPY, POWERED
Product CodeIOQ
Date Received2018-04-13
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 2018-04-13

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