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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765; TOOTHBRUSH, POWERED

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BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765; TOOTHBRUSH, POWERED Back to Search Results
Model Number 3765
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Scar Tissue (2060); Unspecified Tissue Injury (4559)
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
Bleeding [haemorrhage].Scar on face [scar].Puncture marks in cheek/cuts - gums [gingival injury].Brush end has been coming off when brushing my teeth - oral-b [device breakage].Head is loose on the brush - oral-b [device connection issue].Consumer via e-mail stated that the attachment for the brush end was loose on the toothbrush and coming off while brushing their teeth.This resulted in puncture marks/cuts in their cheek.No serious injury was reported.18-oct-2021 follow up: the consumer reported that they did not seek medical attention and used a strong compress to stop the bleeding.It also left a scar on their face.No serious injury was reported.
 
Event Description
Bleeding [haemorrhage].Scar on face [scar].Puncture marks in cheek/cuts - gums [gingival injury].Brush end has been coming off when brushing my teeth - oral-b [device breakage].Head is loose on the brush - oral-b [device connection issue].Consumer via e-mail stated that the attachment for the brush end was loose on the toothbrush and coming off while brushing their teeth.This resulted in puncture marks/cuts in their cheek.No serious injury was reported.18-oct-2021 follow up: the consumer reported that they did not seek medical attention and used a strong compress to stop the bleeding.It also left a scar on their face.No serious injury was reported.
 
Manufacturer Narrative
19-jan-2022 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by a breakage of the tip of the driving shaft due to improper consumer handling, storing and cleaning of the product.
 
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Brand Name
ORALBPWRRCHGTOOTHBRUSHHANDLE3765
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 Key12835937
MDR Text Key282113736
Report Number3000302531-2021-00372
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
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 10/07/2021
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 Number3765
Device Lot NumberBC810221350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/07/2021
Initial Date FDA Received11/18/2021
Supplement Dates Manufacturer Received01/19/2022
Supplement Dates FDA Received02/01/2022
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 Reuse
Patient Sequence Number1
Treatment
ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORAL-B BRUSHHEADS, VERSION UNKNOWN.
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