MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. A&H SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT 2 CT; POWERED TOOTHBRUSH

Model Number 6687800080

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2020

Event Type  malfunction  

Event Description

The consumer alleges that one brush head split all the way up the seams after three uses and that the other brush head had the same issue after two uses.

• Brand Name: A&H SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT 2 CT
• Type of Device: POWERED TOOTHBRUSH
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing, nj
• Manufacturer (Section G): HAYCO LTD.; 4f citicorp centre; 18 whitfield road; causeway bay, hong kong ; CH
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, nj ; 8067868
• MDR Report Key: 9950397
• MDR Text Key: 198175637
• Report Number: 2280705-2020-00011
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6687800080
• Device Lot Number: DD9214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1