MAUDE Adverse Event Report: CHURCH & DWIGHT CO., INC. A&H SPINBRUSH UNSPECIFIED; POWERED, TOOTHBRUSH, PRODUCT CODE: JEQ

Lot Number DD419883

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Choking (2464); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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 by church & dwight actually occurred.Also, please note that this report is being submitted late due to technical issues with the esg help desk establishing my production account.All emails with the esg help desk regarding this issue have been saved and can be provided if necessary.

Event Description

The consumer reported that the top popped off of a spinbrush during use and went down her throat, causing choking.Additionally, the consumer wanted to know where this product was manufactured and if we have received similar complaints.The consumer initially reported this situation to the fda.A representative from the fda contacted the quality assurance manager at church & dwight co., inc.With this information.An employee at church & dwight co., inc.Returned the fda representative's phone call.The fda representative stated that the consumer didn't have any packaging or lot code information.The consumer had not contacted church & dwight co., inc.Regarding this situation.The consumer told the fda representative that she has purchased a couple of these products.The first one was purchased about six months ago.The consumer claims to replace the product head every 30 days or so.The consumer stated that she's had the whole brush head come off once before, but the second time it came off and went down her throat causing her to choke.This only occurs when the consumer is brushing her tongue.The fda representative called the consumer and asked her if she was willing to speak to an employee at church & dwight co., inc.The fda representative called the church & dwight co., inc.Employee back with the consumer's contact information.The church & dwight co., inc.Employee called the consumer to speak with her regarding her experience.The consumer stated that her experience was very scary and she wanted someone to know about it.She thought the head coming off the brush the first time was a fluke, but after the second time she had to let someone know about it.She confirmed that the entire brush head (the piece you put on the handle) came off while in her mouth and went down her throat.She was able to reach in and grab the end of it and pull it out.She also confirmed that the brush did not break but the whole head came off and flew down her throat.She also stated that now that the head is back on the brush, it is difficult to remove it.The consumer was willing to return the brush head and handle to us.The materials were sent to her to send us the brush.At this point, we have not received it.Additional information received on july 16, 2019: we received the arm and hammer spinbrush and spinbrush questionnaire.Per ade questionnaire: " i was brushing my teeth, it exploded.My dentist told me there was a mark on my gum.".

• Brand Name: A&H SPINBRUSH UNSPECIFIED
• Type of Device: POWERED, TOOTHBRUSH, PRODUCT CODE: JEQ
• Manufacturer (Section D): CHURCH & DWIGHT CO., INC.; 500 charles ewing boulevard; ewing NJ 08628
• Manufacturer (Section G): HAYCO MANUFACTURING LTD.; 4f citicorp centre; 18 whitfield rd.; causeway bay, hong kong, ; CH
• Manufacturer Contact: stacey harshaw ; 469 north harrison street; princeton, NJ 08543 ; 6098067868
• MDR Report Key: 8908710
• MDR Text Key: 204454192
• Report Number: 2280705-2019-00018
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: DD419883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other