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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSKIDS4706; TOOTHBRUSH, POWERED
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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSKIDS4706; TOOTHBRUSH, POWERED Back to Search Results
Lot Number A634
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2018 product investigation results: reporter returned toothbrush head on (b)(6) 2018.Product return was received and investigated.Investigation results showed that complaint was caused by a breakage due to an effect of force because of consumer handling.
 
Event Description
Consumer sent e-mail stating toothbrush head cracked.No injury was reported.
 
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Brand Name
ORALBPWRPWRORALCARERFLSKIDS4706
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
Manufacturer (Section G)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM   D-97828
Manufacturer Contact
regulatory oral care
8700 mason-montgomery rd
mason, OH 45040
MDR Report Key7573788
MDR Text Key110473699
Report Number3000302531-2018-00151
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 04/16/2018
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 NumberA634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/16/2018
Initial Date FDA Received06/06/2018
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 Number1
Patient Age3 YR
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