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

Model Number EB 17

Device Problems Crack (1135); Defective Component (2292); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Based on available information this product is suspected to be a non-genuine oral-b product.Return of product has been requested.Product and production code / 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

Blood on toothbrush - mouth [mouth haemorrhage].Plastic housing cracked and a piece of metal was sticking out of the top, discovered problem with this defective product after i saw my blood on the toothbrush and in the sink - oral-b brushhead [injury associated with device].Plastic housing cracked and a piece of metal was sticking out of the top - oral-b brushhead [device breakage].Case description: a consumer of unspecified age and gender reported spontaneously via e-mail on 24-oct-2017 that a while back he/she bought a 3 pack of oral-b brushheads, version unknown (extrasoft) for his/her oral-b rechargeable toothbrush, version unknown.The consumer described that when he/she used the first brush head out of the pack, starting with the first or second time he/she used it, the plastic housing cracked and a piece of metal was sticking out of the top.The consumer stated that he/she discovered the problem with this defective product after he/she saw his/her blood on the toothbrush and in the sink.The consumer had been an oral-b user for years and had never had a problem like this.The consumer noted that he/she did not use excessive force when brushing.The consumer discontinued use of the product.The overall case outcome was unknown.Treatment details: unknown.No further information was provided.

• 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
• Manufacturer Contact: regulatory oral care
• MDR Report Key: 7044499
• MDR Text Key: 93249767
• Report Number: 3000302531-2017-00400
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

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 Model Number: EB 17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2017
• 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