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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET4CT; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET4CT; TOOTHBRUSH, POWERED Back to Search Results
Model Number EB20
Device Problem Break (1069)
Patient Problems Laceration(s) (1946); Pain (1994); 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
Tore gum.Discomfort gums.Heads break of in my mouth, moving brush head bit falls off the shaft exposing the plastic end with the moving pin - oral-b.Consumer via e-mail stated that in last 2 years, they have had 3 brush heads break off in their mouth.The moving brush head bit falls off the shaft exposing the plastic end with the moving pin.They had dismissed this as wear and tear, but the latest event that occurred today caused them discomfort, tearing their gum when it came off.They reported having soft gums.No serious injury was reported.
 
Event Description
Tore gum [gingival injury], discomfort gums [gingival discomfort], pain - gums [gingival pain], heads break of in my mouth, moving brush head bit falls off the shaft exposing the plastic end with the moving pin - oral-b [device breakage].Case description: consumer via e-mail stated that in last 2 years, they have had 3 brush heads break off in their mouth.The moving brush head bit falls off the shaft exposing the plastic end with the moving pin.They had dismissed this as wear and tear, but the latest event that occurred today caused them discomfort, tearing their gum when it came off.They reported having soft gums.No serious injury was reported.03-may-2021 follow up via e-mail: the consumer reported that they experienced pain and that they have not received any medical attention.No serious injury was reported.
 
Manufacturer Narrative
Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.
 
Event Description
Tore gum [gingival injury]; discomfort gums [gingival discomfort]; pain - gums [gingival pain]; heads break of in my mouth, moving brush head bit falls off the shaft exposing the plastic end with the moving pin - oral-b [device breakage]; product counterfeit [product counterfeit].Consumer via e-mail stated that in last 2 years, they have had 3 brush heads break off in their mouth.The moving brush head bit falls off the shaft exposing the plastic end with the moving pin.They had dismissed this as wear and tear, but the latest event that occurred today caused them discomfort, tearing their gum when it came off.They reported having soft gums.No serious injury was reported.03-may-2021 follow up via e-mail: the consumer reported that they experienced pain and that they have not received any medical attention.No serious injury was reported.
 
Manufacturer Narrative
20-jul-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
ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET4CT
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key11812601
MDR Text Key261223862
Report Number3000302531-2021-00178
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 04/29/2021
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 Model NumberEB20
Device Lot Number4210201848233
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Initial Date Manufacturer Received 04/29/2021
Initial Date FDA Received05/12/2021
Supplement Dates Manufacturer Received05/03/2021
07/20/2021
Supplement Dates FDA Received06/02/2021
08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.
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