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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3766; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number 3766
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Smelled an electrical burning.Cable on electric toothbrush charger (plugged in) was smouldering.Burn through protective cable coating - oral-b [device physical property issue] case narrative: consumer via e-mail stated that they smelled an electrical burning in their bathroom this morning ((b)(6) 2022 and around lunch time.Later, they found that the cable on their oral-b electric toothbrush charger (plugged in) was "smouldering" and the burn went right through the protective cable coating.No injury was reported.On 23-mar-2022 follow up via image: the suspect product lot was 2 ab916 12357.No injury was reported.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Manufacturer Narrative
On 10-may-2022 product investigation results: product return was received and investigated.Product investigation results showed that complaint was caused by a breakage of the mains cable due to improper consumer handling.
 
Event Description
Smelled an electrical burning.Cable on electric toothbrush charger (plugged in) was smouldering.Burn through protective cable coating - oral-b [device physical property issue] case narrative: consumer via e-mail stated that they smelled an electrical burning in their bathroom this morning (b)(6) 2022 and around lunch time.Later, they found that the cable on their oral-b electric toothbrush charger (plugged in) was "smouldering" and the burn went right through the protective cable coating.No injury was reported.23-mar-2022 follow up via image: the suspect product lot was 2 ab916 12357.No injury was reported.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3766
Type of Device
TOOTHBRUSH, POWERED - JEQ
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
mgr. affairs, oral care-see co
mason business center 8700
mason-montgomery rd
mason 45040
MDR Report Key14163515
MDR Text Key294598903
Report Number3000302531-2022-00150
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)Y
Reporter Country CodeUK
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 05/23/2022
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 Model Number3766
Device Lot Number2 AB916 12357
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/20/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/24/2022
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
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