POWER PACK, EXTENDED LIFE 0408660000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-25 for POWER PACK, EXTENDED LIFE 0408660000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[112166605] The sales representative reported that the device heated up while testing it at a facility. There were no reported adverse consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2018-01087
MDR Report Key7633661
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-06-25
Date of Report2018-06-25
Date of Event2018-05-30
Date Mfgr Received2018-05-30
Device Manufacturer Date2018-03-02
Date Added to Maude2018-06-25
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. ZACH BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOWER PACK, EXTENDED LIFE
Generic NameHELMET, SURGICAL
Product CodeFXZ
Date Received2018-06-25
Returned To Mfg2018-06-04
Catalog Number0408660000
Lot Number20180302
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-25

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