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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLOSS ACTION BRUSH HEAD; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLOSS ACTION BRUSH HEAD; TOOTHBRUSH, POWERED Back to Search Results
Lot Number 9117331
Device Problems Detachment of Device or Device Component (2907); 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 via phone stated that when they were using the oral-b floss action brush head, the metal piece that was inside of the brush head came out and fell in their mouth.The brush head does not sit on the handle and it does not rotate any more.No injury was reported.
 
Manufacturer Narrative
22-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.
 
Event Description
Consumer via phone stated that when they were using the oral-b floss action brush head, the metal piece that was inside of the brush head came out and fell in their mouth.The brush head does not sit on the handle and it does not rotate any more.No injury was reported.
 
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Brand Name
ORAL-B FLOSS ACTION BRUSH HEAD
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 Key12360819
MDR Text Key274442728
Report Number3000302531-2021-00285
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/06/2021
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 Number9117331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/06/2021
Initial Date FDA Received08/24/2021
Supplement Dates Manufacturer Received12/22/2021
Supplement Dates FDA Received01/05/2022
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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