FDA.reportPublic FDA data

MAUDE MDR 2495962

MDR report key
2495962
Report number
2495962
Event key
0
Event type
3
Date of event
2012-03-15
Date received
2012-03-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAREFUSIONSURGICAL HAND SCRUBCAREFUSIONGECNDC-57613-007-25*0000402093 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-150

Event Narratives#

D

Patient 1

A SURGEON OPENED A NEW PACKAGE OF SURGICAL HAND SCRUB AND DISCOVERED WHAT HE THOUGHT WAS A "BUG" STUCK ON THE BRISTLES. THE PRODUCT WAS SEQUESTERED AND NOT USED. THE MANUFACTURER NOTIFIED AND THEY WILL SEND A MAILER TO RETURN PRODUCT FOR ANALYSIS.