CHEMO SAFETY GOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-19 for CHEMO SAFETY GOWN manufactured by Tyco/kendall.

Event Text Entries

[19692182] Fyi - in regards to the quarterly action report item about chemoplus gowns - this problem is not limited to chemoplus brand. Xxxxxx purchased "chemo safety" gowns (tyco/kendall) and found that these gowns are also liquid-permeable (not "polymer-coated") despite the name "chemo safety" - other institutions may also be "fooled" by the name of a product assuming "chemo" means osha approved impermeable gowns. Thanks for the alert... The qaa's and med safety alerts are indispensable. The safety gowns from this institution that were purchased for protection against "liquids" also proved to be permeable to liquid substances. This was discovered when tested with venofer by one of the pharmacists. There was no effect obvious using the unprotected gowns however the concern on their part is not using appropriate gowns for an unk period of time. They immediately purchased the chemoplus coated gowns from their wholesaler and removed the old gowns from stock the next day. When and how was error discovered: the reporter was going through the ismp quarterly action agenda and checked, double-checked, their gowns. Although they were not the chemoplus gown, they were obviously not polymer coated and when tested with venofer by one of the pharmacists, it was obviously liquid permeable. Reporter's recommendations: they are trying to find out the source as kendall is now owned by covidien. Their kendall/tyco "chemosafety" brand may be discontinued, but this reporter's institution had a large number in stock, and it might still be in wholesalers: (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5027014
MDR Report Key2756301
Date Received2012-09-19
Date Added to Maude2012-09-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCHEMO SAFETY GOWN
Generic NameCHEMO SAFETY GOWN
Product CodeOEA
Date Received2012-09-19
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerTYCO/KENDALL


Patients

Patient NumberTreatmentOutcomeDate
10 2012-09-19

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