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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B CROSSACTION POWER BRUSHHEADS; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B CROSSACTION POWER BRUSHHEADS; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Consumer reported via e-mail that metal pin fell out of brushhead.No injury was reported.
 
Event Description
Consumer reported via e-mail that metal pin fell out of brushhead.No injury was reported.
 
Manufacturer Narrative
06-dec-2021 product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.
 
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Brand Name
ORAL-B CROSSACTION POWER 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 Key12121062
MDR Text Key262863870
Report Number3000302531-2021-00229
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/10/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received07/06/2021
Supplement Dates Manufacturer Received12/06/2021
Supplement Dates FDA Received12/21/2021
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 Unknown
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.
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