FDA.reportPublic FDA data

MAUDE MDR 5630051

MDR report key
5630051
Report number
MW5062073
Event key
0
Event type
3
Date of event
2016-04-15
Date received
2016-04-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1STANLEY KISSES TAGSSTANLEY KISSES TAGSSTANLEYILQ* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-2901. O

Event Narratives#

D

Patient 1

CONCERN: KISSES TAGS ARE NOT BONDING WITH THE HUGS TAGS. THIS PAST YEAR THE COMPANY CHANGED FROM A KISS TAG (MOTHERS) THAT HAD BATTERY LIFE FOR ONE YEAR, TO A TAG WITH BATTERY LIFE FOR THREE MONTHS. SINCE THEN WE HAVE TO REPLACE TAGS EVERY THREE MONTHS. THE QUALITY OF BONDING HAS DRAMATICALLY DECREASED. DEFINITIONS: HUGS TAGS ARE THE TAG ON INFANTS THAT ALARM WHEN BABY GETS CLOSE TO ENTRANCE/EXITS. KISS TAG IS THE MOTHER'S TAG THAT CHIMES/LULLABIES WHEN BONDED WITH THEIR BABIES HUG TAG. PURPOSE IS TO GIVE INDICATIONS IF WRONG BABY IS GIVEN TO WRONG MOTHER. DATA: SINCE (B)(6) THERE HAS BEEN AN INCREASE IN KISSES TAGS NOT BONDING WITH THE HUGS TAGS; 63 WERE REPORTED BY CCCS. WE HAVE USED THIS PRODUCT FOR YEARS WITH NO ISSUES. WHEN THE MANUFACTURER CHANGED THE BATTERY LIFE, THEY DO NOT WORK ANYMORE. THIS LACK OF BONDING OF THE TWO BRACELETS LEADS TO AN EROSION OF TRUST FOR BOTH THE CUSTOMER AND THE STAFF.