FDA Adverse Event Summary report: N

TEETHING TOY

MDR report key: 7453683 · Received April 23, 2018

Report

Report Number
MW5076647
Date Received
April 23, 2018
Manufacturer
TOMY INTERNATIONAL, INC.
Product Code
MEF
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
OTHER CAREGIVERS

Narratives

Description of Event or Problem · 1

CHILD CHEWING ON TEETHING TOY - WIRE UNDER RUBBERY SURFACE BROKE THROUGH POKING CHILD IN THE MOUTH. SMALL WIRE COULD HAVE BEEN SWALLOWED, AS I COULD PULL IT OUT AFTER TAKEN FROM CHILD. THE WIRE IS VERY SHARP AT BOTH ENDS. I ASSUME IT BROKE AT BOTH ENDS. NURSERY EQUIPMENT AND SUPPLIES. THE FIRST YEARS LEARNING CURVE? DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
292554 TEETHING TOY TEETHING RING MEF TOMY INTERNATIONAL, INC.

Patients

Seq Age Sex Outcome Treatment
1 2 YR