MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSPRECISIONCLEAN4704BRUSHSET4CT; TOOTHBRUSH, POWERED

Model Number 4704

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

Patient Problem No Code Available (3191)

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

Gagging/ throat [retching], head that holds the bristles fell off in mouth / head of brush head detaching in mouth while using it [device breakage].Consumer called and stated that while brushing, the actual head that holds the bristles off fell off in his mouth; he also experienced the head of another brush head detaching in his mouth while he was using it.No serious injury was reported.

Event Description

Gagging/ throat [retching].Head that holds the bristles fell off in mouth / head of brush head detaching in mouth while using it [device breakage].Product counterfeit [product counterfeit].Case description: consumer called and stated that while brushing, the actual head that holds the bristles off fell off in his mouth; he also experienced the head of another brush head detaching in his mouth while he was using it.No serious injury was reported.

Manufacturer Narrative

18-apr-2019 product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.

• Brand Name: ORALBPWRPWRORALCARERFLSPRECISIONCLEAN4704BRUSHSET4CT
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 8513642
• MDR Text Key: 142128961
• Report Number: 3000302531-2019-00063
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4704
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• Patient Age: 65 YR