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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED - JEQ

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED - JEQ Back to Search Results
Model Number EB20
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Discomfort (2330)
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
Uncomfortable [discomfort].Head became loose on the handle - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head became loose on the oral-b toothbrush handle, making it difficult and uncomfortable to use.No serious injury was reported.
 
Manufacturer Narrative
25-jan-2023 case update: the reporter informed the company that the product has been discarded.
 
Event Description
Uncomfortable [discomfort]; head became loose on the handle - oral-b [device connection issue].Case narrative: consumer via e-mail stated that the oral-b toothbrush head became loose on the oral-b toothbrush handle, making it difficult and uncomfortable to use.No serious injury was reported.23-jan-2023 follow up via images: the suspect product was oral-b power oral care refills precision clean eb20.No serious injury was reported.25-jan-2023 follow up via e-mail: the consumer reported that the device was discarded.No serious injury was reported.
 
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Brand Name
ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20
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 ma
son-montgomery rd
mason 45040
MDR Report Key16136502
MDR Text Key308837632
Report Number3000302531-2023-00013
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 02/14/2023
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
Device Operator Lay User/Patient
Device Model NumberEB20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/11/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/14/2023
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
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O).; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (O).
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