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

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Material Fragmentation (1261); Sticking (1597)

Patient Problem Pain (1994)

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 returned product.

Event Description

Sore spot in mouth [oral pain].Object got stuck in gums [foreign body].Brushhead pen had broken off into multiple pieces [device breakage].Sharp object got stuck in gums and noticed brushhead pen had broken off into multiple pieces, sore spot in mouth [injury associated with device].Case description: a consumer of unspecified age and gender reported that he or she was brushing his or her teeth on (b)(6) 2016 with an oral-b rechargeable toothbrush, version unknown, when suddenly a sharp object got stuck in his or her gums.The consumer checked and noticed that the pen of the oral-b brushhead, version unknown had broken off into multiple pieces.The consumer reported that he or she was able to get it out of his or her mouth.The case outcome was improved.No further information was provided.On (b)(6) 2016 received consumer follow-up: the consumer described that it was the newest brush, bigger, and rubbed against each other against the grain.He or she stated that there were 2 brush heads in the pack, and that he or she did not dare to use the other one.The consumer scratched the logo and nothing happened.The overall case outcome remained improved.No further information was provided.On (b)(6) 2016 received consumer follow-up: the consumer reported that he or she still had a sore spot in his or her mouth after using the oral-b flexisoft brushhead.The overall case outcome remained improved.No further information was provided.

• Brand Name: ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer Contact: regulatory oral care ; 8700 mason montgomery road; mason, OH 45040
• MDR Report Key: 5673015
• MDR Text Key: 46785451
• Report Number: 3000302531-2016-00234
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2016
• 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