AAMI 4 SMARTSLEEVE SURG GOWN LG 9011

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 2020-03-25 for AAMI 4 SMARTSLEEVE SURG GOWN LG 9011 manufactured by Cardinal Health Singapore 225 Pte. Ltd..

MAUDE Entry Details

Report Number1423537-2020-00443
MDR Report Key9881242
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-25
Date of Report2020-03-27
Date of Event1980-01-01
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-25
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 ContactPATRICIA TUCKER
Manufacturer Street1500 WAUKEGAN RD
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874151
Manufacturer G1CARDINAL HEALTH SINGAPORE 225 PTE. LTD.
Manufacturer Street10 KALLANG AVENUE #10-10/18 APERIAN
Manufacturer CityEL PASO TX 339510
Manufacturer CountrySN
Manufacturer Postal Code339510
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAAMI 4 SMARTSLEEVE SURG GOWN LG
Generic NameGOWN, SURGICAL
Product CodeFYA
Date Received2020-03-25
Model Number9011
Catalog Number9011
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH SINGAPORE 225 PTE. LTD.
Manufacturer Address10 KALLANG AVENUE #10-10/18 APERIAN TX 339510 SN 339510


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-25

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