MAUDE MDR 2756301

MDR report key
2756301
Report number
MW5027014
Event key
0
Event type
3
Date received
2012-09-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHEMO SAFETY GOWNCHEMO SAFETY GOWNTYCO/KENDALLOEA

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-190

Event Narratives#

D

Patient 1

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).