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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN4704BRUSHSET4CT; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN4704BRUSHSET4CT; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problem Detachment Of Device Component (1104)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Return of product has been requested.Reporter returned toothbrush head on 11-jun-2018.Product investigation is in progress.
 
Event Description
Consumer e-mailed stating that the small head on the end of the brush head popped off.No injury was reported.
 
Manufacturer Narrative
(b)(6)-2018 product investigation results: reporter returned toothbrush head on (b)(6) 2018.Toothbrush head confirmed to be counterfeit.
 
Event Description
Consumer e-mailed stating that the small head on the end of the brush head popped off.No injury was reported.
 
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Brand Name
ORALBPWRPWRORALCARERFLSPRECISIONCLEAN4704BRUSHSET4CT
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key7629159
MDR Text Key112340435
Report Number3000302531-2018-00161
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
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