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MAUDE Adverse Event Report: BRAUN GMBH ORAL B ELECTRIC TOOTHBRUSH; TOOTHBRUSH, POWERED
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BRAUN GMBH ORAL B ELECTRIC TOOTHBRUSH; TOOTHBRUSH, POWERED
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Health Effect - Clinical Code
Unspecified Infection (1930)
Date of Event
05/01/2025
Type of Reportable Event
Serious Injury
Event or Problem Description
Oral b toothbrush has replaceable heads that grow mold.I saw mold growing out of one of the holes on the rotating heads along the stem.I've had sinus infections for the last year.
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Brand Name
ORAL B ELECTRIC TOOTHBRUSH
Common Device Name
TOOTHBRUSH, POWERED
Manufacturer
(Section D)
BRAUN GMBH
MDR Report Key
22187493
Report Number
MW5171328
Device Sequence Number
17718894
Product Code
JEQ
Combination Product (Y/N)
N
Initial Reporter State
GA
Initial Reporter Country
US
Number of Events Summarized
1
Summary Report (Y/N)
N
Reporter Type
Voluntary
Initial Reporter Occupation
Patient
Type of Report
Initial
Report Date
(Section B)
05/31/2025
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
Yes
Operator of Device
Lay User/Patient
Was Device Available for Evaluation?
Yes
Initial Date Received by Manufacturer
Not provided
Initial Report FDA Received Date
06/11/2025
Patient Sequence Number
1
Outcome Attributed to Adverse Event
Disability;
Patient Age
74 YR
Patient Sex
Female
Patient Weight
67 KG
Patient Ethnicity
Non Hispanic
Patient Race
White
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