FDA Adverse Event Malfunction Summary report: N

SPINBRUSH PRO CLEAN REPLACEMENT HEAD MEDIUM 2 CT

MDR report key: 11456863 · Received March 10, 2021

Report

Report Number
2280705-2021-00006
Event Type
Malfunction
Date Received
March 10, 2021
Date of Event
February 24, 2021
Report Date
February 4, 2022
Manufacturer
CHURCH & DWIGHT CO., INC.
Product Code
JEQ
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
WI, US
Reporter Occupation
OTHER
Health Professional
N

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED BECAUSE WE RECEIVED ADDITIONAL INFORMATION REGARDING THE SPECIFIC PRODUCT NAME AND UPC NUMBER.

Additional Manufacturer Narrative · 0

THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED BECAUSE WE RECEIVED ADDITIONAL INFORMATION REGARDING THE SPECIFIC PRODUCT NAME AND UPC NUMBER.

Description of Event or Problem · 0

THE CONSUMER REPORTED THAT HER HUSBAND HAS HAD HIS SPIN-BRUSH FOR LESS THAN SIX MONTHS. MORE SPECIFICALLY, HE HAS BEEN USING THIS PARTICULAR BRUSH WITH THE ORIGINAL BRUSH HEAD FOR ABOUT ONE TO THREE MONTHS. SHE STATED THAT THE BACK OF THE HEAD OF THE BRUSH BROKE OFF IN HIS MOUTH WHILE HE WAS BRUSHING HIS TEETH. THE PIECE IS COMPLETELY DETACHED FROM THE TOOTHBRUSH. THE CONSUMER ALSO STATED THAT THE EDGES OF THE BROKEN PIECE ARE SHARP. HE DID NOT SWALLOW IT AND IT DIDN'T CAUSE ANY DAMAGE. THIS IS BEING REPORTED BASED ON THE ALLEGATION OF A MALFUNCTION (SMALL PART BREAKAGE) WITH THE POTENTIAL TO CAUSE SERIOUS INJURY (CHOKING).

Description of Event or Problem · 0

THE CONSUMER REPORTED THAT HER HUSBAND HAS HAD HIS SPINBRUSH FOR LESS THAN SIX MONTHS. MORE SPECIFICALLY, HE HAS BEEN USING THIS PARTICULAR BRUSH WITH THE ORIGINAL BRUSH HEAD FOR ABOUT ONE TO THREE MONTHS. SHE STATED THAT THE BACK OF THE HEAD OF THE BRUSH BROKE OFF IN HIS MOUTH WHILE HE WAS BRUSHING HIS TEETH. THE PIECE IS COMPLETELY DETACHED FROM THE TOOTHBRUSH. THE CONSUMER ALSO STATED THAT THE EDGES OF THE BROKEN PIECE ARE SHARP. HE DID NOT SWALLOW IT AND IT DIDN'T CAUSE ANY DAMAGE. THIS IS BEING REPORTED BASED ON THE ALLEGATION OF A MALFUNCTION (SMALL PART BREAKAGE) WITH THE POTENTIAL TO CAUSE SERIOUS INJURY (CHOKING).

Additional Manufacturer Narrative · 1

THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED.

Description of Event or Problem · 1

THE CONSUMER REPORTED THAT HER HUSBAND HAS HAD HIS SPINBRUSH FOR LESS THAN SIX MONTHS. MORE SPECIFICALLY, HE HAS BEEN USING THIS PARTICULAR BRUSH WITH THE ORIGINAL BRUSH HEAD FOR ABOUT ONE TO THREE MONTHS. SHE STATED THAT THE BACK OF THE HEAD OF THE BRUSH BROKE OFF IN HIS MOUTH WHILE HE WAS BRUSHING HIS TEETH. THE PIECE IS COMPLETELY DETACHED FROM THE TOOTHBRUSH. THE CONSUMER ALSO STATED THAT THE EDGES OF THE BROKEN PIECE ARE SHARP. HE DID NOT SWALLOW IT AND IT DIDN'T CAUSE ANY DAMAGE. THIS IS BEING REPORTED BASED ON THE ALLEGATION OF A MALFUNCTION (SMALL PART BREAKAGE) WITH THE POTENTIAL TO CAUSE SERIOUS INJURY (CHOKING).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
354657 SPINBRUSH PRO CLEAN REPLACEMENT HEAD MEDIUM 2 CT POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800081 DD9228A2

Patients

Seq Age Sex Outcome Treatment
1 Male