MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B POWERPOLISHER BRUSHHEADS; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Product return was not received.Product return was requested.Full evaluation will occur upon receipt of returned product.

Event Description

Bleed- mouth [mouth haemorrhage].Cut, stab to cheek- mouth [mouth injury].Brush head shoots off in mouth [device breakage].Consumer contacted via phone and stated that he started to brush his teeth and the brush head shot off in his mouth.No serious injury was reported.Follow-up: the consumer stated that he did not always purchase the same type of brush head; various brush heads had come off.

• Brand Name: ORAL-B POWERPOLISHER BRUSHHEADS
• 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
• MDR Report Key: 9700029
• MDR Text Key: 191198246
• Report Number: 3000302531-2020-00031
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2020

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 Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/12/2020
• 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 Number: 1