FDA.reportPublic FDA data

MAUDE MDR 125996

MDR report key
125996
Report number
MW4002018
Event key
0
Event type
3
Date received
1997-10-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEMPA-DOTCOLOR CHANGE THERMOMETERPYMAH CORP.FQZ**C234AN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-10-100

Event Narratives#

D

Patient 1

RPTR IS ASSISTANT DIRECTOR AT BLOOD BANK, RPTR WAS AUDITING THE BLOOD BANK, AND WHEN THEY WERE INSPECTING DONOR'S AREA THEY FOUND THEY WERE USING AN PRODUCT TO MEASURE TEMPERATURE CALLED TEMPA-DOT. AS SOON AS RPTR FOUND THIS PRODUCT THEY CONCLUDED IT WAS EXPIRED. THEY CLOSED THAT AREA UNTIL THEY ARE ABLE TO GET MORE INFO. THE PRODUCT BOX HAD A DIFFERENT LABEL: EXP AS EXPEDITION DATE AND VAL AS VALID DATE. RPTR TRIED TO CALL THE PYMATT CORP IN SOMERVILLE NJ, TO GET MORE INFO ABOUT THE LOT NUMBER AND TO CLARIFY, BUT THE PHONE NUMBER HAD CHANGED. RPTR DOES NOT KNOW FOR SURE IF "EXP" IS FOR EXPIRATION OR EXPEDITION DATE.