MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Return of product has been requested.Product and lot number not provided by the reporter, therefore unable to proceed with product investigation at this time.Full evaluation will occur upon receipt of the returned product.

Event Description

Toothbrush head fell apart whilst in use, heads crack and break off [device breakage].No adverse event [no adverse event].Case description: a consumer of unspecified age and gender reported via e-mail on (b)(6) 2017 that while using an oral-b rechargeable toothbrush, version unknown, the oral-b brushhead, version unknown fell apart.The reporter stated the brush heads crack and break off, and the toothbrush unit then bands the gums once the head fell off.This has happened with 2 brush heads from the pack of 8.No symptoms developed.(b)(6) 2017 consumer follow-up via e-mail: the consumer reported the brush heads were oral-b power oral care refills precision clean.The consumer attempted to scratch the logo and reported it would not scratch off.No further information was provided.

• Brand Name: ORALBPWRPWRORALCARERFLSPRECISIONCLEAN
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer Contact: regulatory oral care ; 8700 mason montgomery road; mason, OH 45040
• MDR Report Key: 6604600
• MDR Text Key: 76710921
• Report Number: 3000302531-2017-00217
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2017

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
• Device Lot Number: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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