FDA.reportPublic FDA data

MAUDE MDR 7665758

MDR report key
7665758
Report number
MW5078277
Event key
0
Event type
3
Date of event
2018-07-02
Date received
2018-07-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MCKESSON SURGICAL LUBRICANTLUBRICANT, PATIENTUNKKMJ16-8946CHB11-01I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-050

Event Narratives#

D

Patient 1

I HAVE PREVIOUSLY ORDERED AND USED A SURGICAL LUBRICANT MCKESSON MR #119-8946 - THIS IS A 5 GRAM PACKET. IT IS A GOOD PRODUCT AND IT IS MADE IN THE USA. MY SUPPLIER SUBSTITUTED MCKESSON MFR #16-8946 WHICH IS MADE IN (B)(4) AND IT IS OF VERY POOR QUALITY. NOTE THAT THE LAST FOUR DIGITS OF THESE TWO PRODUCTS ARE THE SAME. IT IS THE FIRST 2-3 DIGITS THAT ARE DIFFERENT. THREE OF THE INGREDIENTS IN THE GOOD PRODUCT ARE NOT IN THE BAD PRODUCT. THERE IS A PHENOMENA CALLED WETABILITY THAT CAN BE MEASURED TO DETERMINE HOW WELL SOMETHING SPREADS. I AM GUESSING THAT ONE OF THE INGREDIENTS IN THE GOOD PRODUCT ENHANCES THE WETABILITY. IT SPREADS VERY SMOOTHLY WHEREAS THE (B)(4) PRODUCT BEADS UP INTO LITTLE CLUMPS. THE (B)(4) PRODUCT IS UNSUITABLE AS A SURGICAL LUBRICANT FOR USE IN INTERMITTENT CATHETERIZATION. THIS IS NOT THE FAULT OF MY SUPPLIER BECAUSE THEY LET ME KNOW THAT THE USA PRODUCT IS NO LONGER AVAILABLE. MCKESSON MEDICAL-SURGICAL INC.