COVER GOWN, YELLOW 2100PG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-10 for COVER GOWN, YELLOW 2100PG manufactured by Cardinal Health.

Event Text Entries

[21049474] Nurse had a reaction of facial itching and hives. She was treated in the e. R. On (b)(6) 2014 and started on prednisone and benadryl. On (b)(6) 2014, cardinal health learned that this nurse also apparently had a reaction to the gown back in 2013 ((b)(6) 2013) and sought medical care at that time. She switched to a different gown and was doing fine until (b)(6) 2014 when during a patient emergency she used this gown again. Per the customer, it is unclear if this recent reaction was due to the gown or due to the mask that was used by the nurse. Cardinal health is proactively filing this report.
Patient Sequence No: 1, Text Type: D, B5


[21164706] Since there was no lot number or sample available, we are unable to review the device history record or conduct an investigation to determine if there was any deviation that could have led to this complaint. Therefore the root cause could not be determined. Historical trending was done. This product is made of polypropylene with calcium carbonate fillers. The material has passed a series of tests prescribed by regulatory agencies for the intended use. The complaint was feedback to the relevant production personnel. At this time there will be no corrective action, but we will continue to monitor complaints for any trends of this nature.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423537-2014-00011
MDR Report Key3671056
Report Source05,07
Date Received2014-03-10
Date of Report2014-03-10
Date of Event2014-01-18
Date Mfgr Received2014-02-10
Date Added to Maude2014-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMICHELE DONATICH
Manufacturer Street1430 WAUKEGAN ROAD
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478876412
Manufacturer G1CARDINAL HEALTH 200, LLC
Manufacturer Street1430 WAUKEGAN RD
Manufacturer CityWAUKEGAN 60085
Manufacturer CountryUS
Manufacturer Postal Code60085
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOVER GOWN, YELLOW
Generic NameISOLATION GOWN
Product CodeFYC
Date Received2014-03-10
Catalog Number2100PG
Lot NumberNO LOT GIVEN
OperatorNURSE
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH
Manufacturer AddressMCGAW PARK IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-03-10

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