MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRIRRIGATORORALCENTEROXIJET3724MODELOC20.525.1; TOOTHBRUSH, POWERED

Model Number OC20.525.1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed due to a damaged charger cable.The alleged product malfunction could result in a serious injury with a consumer should such an event occur in the future.Therefore, we are reporting this case out of an abundance of caution.Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Electrical shock [electric shock].(oral-b irrigator caused) electric shock [device physical property issue].Male consumer via e-mail stated that he got an electric shock when using the oral-b oxyjet model 3724 irrigator.

Manufacturer Narrative

10-jan-2022 product investigation results: product return was received and investigated.Based on product investigation results, a manufacturing or design issue can be excluded as no technical fault or defect found which can lead to electric shock that is hazardous.

Event Description

Electrical shock [electric shock].(oral-b irrigator caused) electric shock [device physical property issue].Male consumer via e-mail stated that he got an electric shock when using the oral-b oxyjet model: 3724 irrigator.

• Brand Name: ORALBPWRIRRIGATORORALCENTEROXIJET3724MODELOC20.525.1
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer (Section G): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer Contact: regulatory oral care ; 8700 mason-montgomery rd.; mason, OH 45040
• MDR Report Key: 13051274
• MDR Text Key: 286889759
• Report Number: 3000302531-2021-00406
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OC20.525.1
• Device Lot Number: B026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male