GOWN ISO POLY-COATED W/KNITCUFF UNIV WHT 7300PG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for GOWN ISO POLY-COATED W/KNITCUFF UNIV WHT 7300PG manufactured by Cardinal Health Singapore 225 Pte Ltd.

Event Text Entries

[39641038] (b)(4). The device history record for lot number 15dfy110 did not indicate any exception that could lead to the reported incident. Indicated no abnormal event was detected. This lot number was made in may of 2015. There was no deviation for the raw material, accessories, production equipment, process and environment. The main materials such as cuff and spp/laminated materials for body materials had been subjected to and passed the biocompatibility test prescribed for the intended use of the products. Review of the samples provided confirmed no differences between the returned samples with the production products. This was the first reported incident for 7300pg. From this investigation, the reported problem could not be confirmed and the root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10


[39641039] We are seeing dermatitis when using the white gown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423537-2016-00009
MDR Report Key5467836
Date Received2016-02-29
Date of Report2016-02-29
Date of Event2016-02-08
Date Mfgr Received2016-02-08
Date Added to Maude2016-02-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHELE DONATICH
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478876412
Manufacturer G1CARDINAL HEALTH SINGAPORE 225 PTE LTD
Manufacturer Street10 KALLANG AVENUE
Manufacturer CitySINGAPORE 339510
Manufacturer CountrySN
Manufacturer Postal Code339510
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGOWN ISO POLY-COATED W/KNITCUFF UNIV WHT
Generic NameGOWN ISO POLY-COATED W/KNITCUFF UNIV WHT
Product CodeOEA
Date Received2016-02-29
Model Number7300PG
Catalog Number7300PG
Lot Number15DFY110
OperatorNURSE
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH SINGAPORE 225 PTE LTD
Manufacturer AddressSINGAPORE SN


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-29

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