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

Lot Number DD4270B2

Device Problems Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer reports that "the entire ring near the bottom of the head cracked and came off while i'm using it." this is being reported as a malfunction with the potential to cause a serious event.No injury was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: ARM & HAMMER SPINBRUSH PROCLEAN REPLACEMENT HEAD
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): HAYCO LTD.; 4f citicorp centre; 18 whitfield road; causeway bay, hong kong ; CH
• Manufacturer Contact: lynn moody ; 469 north harrison street; princeton, NJ 08543-5297 ; 6098061431
• MDR Report Key: 4769270
• MDR Text Key: 19344844
• Report Number: 2280705-2015-00024
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/13/2015

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: Other
• Device Lot Number: DD4270B2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1