FDA.reportPublic FDA data

MAUDE MDR 7926395

MDR report key
7926395
Report number
MW5080283
Event key
0
Event type
3
Date of event
2018-09-08
Date received
2018-10-01
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
1AMBER TEETHING NECKLACERING, TEETHING NON-FLUID FILLEDMEFI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-010

Event Narratives#

D

Patient 1

AMBER TEETHING NECKLACES, I HAVE SEEN THEM ON MANY INFANTS AND YOUNG TODDLERS. SO I LOOKED INTO THEM AND THEY ARE MARKETED FOR BABIES. BUT THE WARNING ON AGE IS HIDDEN ON MOST OF THE PAGES. SO MANY DO NOT SEE IT UNLESS YOU DO SOME READING WAY DOWN ON THE WEB PAGE. I FEEL THAT THEY ARE PUTTING CHILDREN AT RISK BECAUSE IT IS A HIDDEN WARNING. I DO NOT FEEL THEY SHOULD BE MISLEADING CONSUMERS ON THE DANGERS OF THIS PRODUCT AND FEEL IT SHOULD BE REMOVED OR NOT BE MARKETED FOR USE ON CHILDREN. PRODUCT TYPE: NURSERY EQUIPMENT AND SUPPLIES; BRAND NAME: MANY OF THEM DON'T KNOW ALL OF THEM. MANUFACTURER: (B)(4) IS JUST ONE OF THE FEW THAT MARKET IT FOR BABIES. MANUFACTURER WEBSITE (B)(4); RETAILER STATE: ONLINE. DOCUMENT NUMBER: (B)(4).