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

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Crack (1135)

Patient Problem Injury (2348)

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 returned product.

Event Description

Caught a part of the lip [lip injury]; brush head failed in a matter of weeks cracks on the back / fell off while in use in mouth / caught a part of lip but is okay [injury associated with device]; brush heads have failed in a matter of weeks and cracks on the back, one fell off whilst in use in mouth [device breakage]; unsure whether they're your brushes or someone else's - oral-b [suspected counterfeit product].Case description: a male consumer of unspecified age reported that he had used 4 oral-b power oral care refills precision clean for the last month and they had failed in a matter of weeks and cracked on the back.He explained that one fell off in his mouth while in use with an oral-b rechargeable toothbrush, version unknown.He stated that they had caught a part of the lip but he was okay.The consumer questioned whether or not they were oral-b brushes or someone else's.This was not the first time the consumer had used these particular brush heads.The case outcome was recovered.No further information was provided.

Manufacturer Narrative

On 28-jul-2016 product investigation results: reporter returned two toothbrush heads on (b)(6) 2016.Toothbrush heads confirmed to be counterfeit.

Event Description

Caught a part of the lip [lip injury]; brush head failed in a matter of weeks cracks on the back / fell off while in use in mouth / caught a part of lip but is okay [injury associated with device]; brush heads have failed in a matter of weeks and cracks on the back, one fell off whilst in use in mouth [device breakage]; product counterfeit [product counterfeit].Case description: a male consumer of unspecified age reported that he had used 4 oral-b power oral care refills precision clean for the last month and they had failed in a matter of weeks and cracked on the back.He explained that one fell off in his mouth while in use with an oral-b rechargeable toothbrush, version unknown.He stated that they had caught a part of the lip but he was okay.The consumer questioned whether or not they were oral-b brushes or someone else's.This was not the first time the consumer had used these particular brush heads.The case outcome was recovered.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: 5730531
• MDR Text Key: 48415544
• Report Number: 3000302531-2016-00281
• 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,Followup
• Report Date: 05/20/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2016
• 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