MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED

Lot Number C636

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Return of product has been requested.Product not provided by the reporter therefore unable to proceed with product investigation at this time.The reporter informed the company that the product had been discarded.

Event Description

Brush head came off [device breakage].The brush head was loose with a gap before it came off completely [device connection issue].No adverse event [no adverse event].Case description: report source: non-event - spontaneous.A consumer of unspecified age and gender reported via e-mail on (b)(6) 2018 that when he/she brushed his/her teeth on (b)(6) 2018 with an oral-b rechargeable toothbrush, version unknown, the oral-b brushhead, version unknown ((b)(4) pro bright) came off and very nearly went down his/her throat.The consumer described that this was the second time that a brush head of this model had malfunctioned, but the last time he/she managed to see that the brush head was loose with a gap before it came off completely.No symptoms developed.Relevant history: none reported.No further information was provided.On 22-jan-2018 received consumer's follow-up e-mail: the consumer reported that he/she thought that he'd/she'd purchased the brush heads about a year ago, and it was a 3-pack of the product.The consumer had one brush head left from the package (he/she had used other brushes in between), but had thrown the defective brushes out.The code on the brush that he/she had left was c636.The consumer stated that he/she could send in the brush that he/she had left.No further information was provided.

Manufacturer Narrative

15-mar-2018 product investigation results: reporter returned an unspecified number of toothbrush heads on 13-mar-2018.Toothbrush heads confirmed to be counterfeit.

Event Description

Brush head came off [device breakage].The brush head was loose with a gap before it came off completely [device connection issue].No adverse event [no adverse event].Product counterfeit [product counterfeit].Case description: report source: non-event - spontaneous.A consumer of unspecified age and gender reported via e-mail on (b)(6) 2018 that when he/she brushed his/her teeth on (b)(6) 2018 with an oral-b rechargeable toothbrush, version unknown, the oral-b brushhead, version unknown (4 704 133-01 pro bright) came off and very nearly went down his/her throat.The consumer described that this was the second time that a brush head of this model had malfunctioned, but the last time he/she managed to see that the brush head was loose with a gap before it came off completely.No symptoms developed.Relevant history: none reported.No further information was provided.22-jan-2018 received consumer's follow-up e-mail: the consumer reported that he/she thought that he'd/she'd purchased the brush heads about a year ago, and it was a 3-pack of the product.The consumer had one brush head left from the package (he/she had used other brushes in between), but had thrown the defective brushes out.The code on the brush that he/she had left was c636.The consumer stated that he/she could send in the brush that he/she had left.No further information was provided.

• Brand Name: ORAL-B BRUSHHEADS, VERSION UNKNOWN
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 7281147
• MDR Text Key: 100581199
• Report Number: 3000302531-2018-00047
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: C636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN