CUB PEDIATRIC CRIB- HYD BASE FL19H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for CUB PEDIATRIC CRIB- HYD BASE FL19H manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[143947008] It was reported that a pediatric patient was in the crib with his parents in the room when he got his thumb entrapped in the canopy option assembly while it was in the raised position. It was reported that a lidocaine nerve block was done for the patient to keep him calm while his thumb was freed from the canopy option assembly. It was reported that it took approximately an hour for the bio-med department to cut away the assembly in order to free the patient's hand.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2019-00560
MDR Report Key8569484
Date Received2019-05-01
Date of Report2019-05-01
Date of Event2019-03-30
Date Mfgr Received2019-04-03
Device Manufacturer Date2015-04-09
Date Added to Maude2019-05-01
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 Report0

Device Details

Brand NameCUB PEDIATRIC CRIB- HYD BASE
Generic NameBED, PEDIATRIC OPEN HOSPITAL
Product CodeFMS
Date Received2019-05-01
Catalog NumberFL19H
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-01

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