MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756PRO2000; TOOTHBRUSH, POWERED

Lot Number 2MAF 70141052

Device Problems Vibration (1674); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Injured when.Metal pin would.Bang up against face- skin [skin injury].Brush heads slipping off toothbrush [device breakage].Metal part to which you attach the brush head is totally flattened and worn down [device physical property issue].Case description: consumer sent e-mail stating the brush heads kept slipping of the toothbrush.The silver piece of the toothbrush that vibrates was quite flat and seemed worn down, and therefore unable to hold the brush head in place.The toothbrush had been used for 3 years.No serious injury was reported.

Manufacturer Narrative

(b)(4)2021 lot code investigation: no failure could be identified, the product is according to specifications.

Event Description

Injured when.Metal pin would.Bang up against face- skin [skin injury] brush heads slipping off toothbrush [device breakage] metal part to which you attach the brush head is totally flattened and worn down [device physical property issue] case description: consumer sent e-mail stating the brush heads kept slipping of the toothbrush.The silver piece of the toothbrush that vibrates was quite flat and seemed worn down, and therefore unable to hold the brush head in place.The toothbrush had been used for 3 years.No serious injury was reported.

Manufacturer Narrative

29-apr-2021: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

Injured when metal pin would bang up against face- skin [skin injury].Brush heads slipping off toothbrush [device breakage].Metal part to which you attach the brush head is totally flattened and worn down [device physical property issue].Consumer sent e-mail stating the brush heads kept slipping of the toothbrush.The silver piece of the toothbrush that vibrates was quite flat and seemed worn down, and therefore unable to hold the brush head in place.The toothbrush had been used for 3 years.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756PRO2000
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 10985963
• MDR Text Key: 227793991
• Report Number: 3000302531-2020-00233
• 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,Followup
• Report Date: 11/11/2020

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: 2MAF 70141052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/12/2021; 04/29/2021
• Supplement Dates FDA Received: 03/11/2021; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORAL-B BRUSHHEADS, VERSION UNKNOWN.; ORAL-B POWER/POWER ORAL CARE REFILLS/CROSSACTION.; ORAL-B POWER/POWER ORAL CARE REFILLS/CROSSACTION.; ORAL-B POWER/POWER ORAL CARE REFILLS/CROSSACTION.