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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product return was not received.Product return was requested.Full evaluation will occur upon receipt of returned product.
 
Event Description
Consumer contacted via phone and stated that she suddenly had a metal pin from the brush head in her mouth; the brush head stopped rotating too.No injury was reported.
 
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Brand Name
ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS
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 Key9249452
MDR Text Key191197614
Report Number3000302531-2019-00192
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeGM
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 09/30/2019
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 NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/30/2019
Initial Date FDA Received10/29/2019
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 Number1
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