Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED Back to Search Results
Lot Number NOT AVAILABLE
Device Problems Break (1069); Device Fell (4014)
Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); 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
Blood - mouth [mouth haemorrhage].Scratch on roof of mouth [mouth injury].Mouth discomfort [oral discomfort].Non-genuine [suspected counterfeit product].After a minute of use the brushhead replacement had broken [device breakage].Consumer letter states that while brushing the replacement brushhead broke and fell off.The metal peg then scratched roof of mouth with a bit of blood and minor discomfort.No serious injury was reported.
 
Manufacturer Narrative
(b)(6)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.
 
Event Description
Blood - mouth [mouth haemorrhage] scratch on roof of mouth [mouth injury] mouth discomfort [oral discomfort] product counterfeit [product counterfeit] after a minute of use the brushhead replacement had broken [device breakage] case description: consumer letter states that while brushing the replacement brushhead broke and fell off.The metal peg then scratched roof of mouth with a bit of blood and minor discomfort.No serious injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORAL-B BRUSHHEADS, VERSION UNKNOWN
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key11769224
MDR Text Key251239928
Report Number3000302531-2021-00164
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
Report Date 04/13/2021
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 Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Initial Date Manufacturer Received 04/13/2021
Initial Date FDA Received05/04/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/09/2021
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
Patient Age63 YR
-
-