MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. ARM & HAMMER SPINBRUSH UNSPECIFIED; POWERED TOOTHBRUSH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Product components are manufactured at the following contract manufacturing locations.Since the consumer has not returned the product to date, we are unable to determine which exact product was used and at which location the particular product was manufactured.Heads are manufactured at the following location: contract mfr.Trisa (b)(4).(b)(4).Contract mfr.Hayco ltd.(b)(4).Contract mfr.Shantou city kin seng plastic co., ltd.(b)(4).

Event Description

While the consumer was brushing her teeth, the toothbrush head came off in her mouth.

• Brand Name: ARM & HAMMER SPINBRUSH UNSPECIFIED
• Type of Device: POWERED TOOTHBRUSH
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 8947028
• MDR Text Key: 156578098
• Report Number: 2280705-2019-00025
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1