MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B DUALACTION OR DUAL CLEAN BRUSHHEADS; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problem Detachment Of Device Component (1104)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Return of product has been requested.Product and lot number not provided by the reporter, therefore unable to proceed with product investigation at this time.Full evaluation will occur upon receipt of the returned product.

Event Description

Consumer called stating the bottom piece of brush head came off with brushing.No serious injury reported.

Manufacturer Narrative

22-jan-2019 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of plastic parts due to usage of abrasive toothpaste in combination with insufficient cleaning.

Event Description

Pinched-top lip, right side [lip injury], bump-top lip, right side [lip disorder], the bottom piece that came off with brushing pinched lip - oral b brush head [injury associated with device], the bottom piece head came off with brushing - oral b brush head [device breakage].Consumer called stating the bottom piece of brush head came off with brushing.No serious injury reported.11-aug-2020 internal review found product investigation update from 22-jan-2019: no manufacturing cause identified based on investigation.

• Brand Name: ORAL-B DUALACTION OR DUAL CLEAN BRUSHHEADS
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 7626160
• MDR Text Key: 112432438
• Report Number: 3000302531-2018-00159
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B POWER RECHARGEABLE TB HANDLE VITALITY; ORAL-B POWER RECHARGEABLE TB HANDLE VITALITY
• Patient Age: 47 YR