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

Lot Number R 446 21603

Device Problems Fitting Problem (2183); Connection Problem (2900)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Injury (2348)

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

Pierced, drilled into the top of lip going through skin into the inside of mouth [lip injury]; lip swelled [lip swelling]; bleeding lip [lip haemorrhage]; pain lip [lip pain]; sore mouth [oral pain]; bruising lip [oral contusion]; lip scar/lump [scar]; tooth brush head came off [device breakage]; brush attachment looser fitting [device connection issue].Case description: consumer sent e-mail stating toothbrush head was looser fitting and came off while brushing her teeth.No serious injury was reported.

Manufacturer Narrative

15-feb-2019 product investigation results: product return was received and evaluated.No failure could be identified, the product is according to specifications.

Event Description

Pierced, drilled into the top of lip going through skin into the inside of mouth [lip injury] lip swelled [lip swelling] bleeding lip [lip haemorrhage] pain lip [lip pain] sore mouth [oral pain] bruising lip [oral contusion] lip scar/lump [scar] tooth brush head came off [device breakage] brush attachment looser fitting [device connection issue] case description: consumer sent e-mail stating toothbrush head was looser fitting and came off while brushing her teeth.No serious injury was reported.Follow-up: product identified as oral-b power precision clean on 06-feb-2019.

• Brand Name: ORALBPWRPWRORALCARERFLSPRECISIONCLEAN
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 8225780
• MDR Text Key: 132569277
• Report Number: 3000302531-2019-00005
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: R 446 21603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B TRIUMPH PROFESSIONAL CARE RECHARGEABLE TB; ORAL-B TRIUMPH PROFESSIONAL CARE RECHARGEABLE TB