MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSDUALACTNUNKBRUSHSET1CT; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Break (1069); Device Fell (4014)

Patient Problems Asphyxia (1851); Foreign Body In Patient (2687)

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

Suffocated me [asphyxia], coughing - throat [cough], gagging - throat [retching], bottom brush fell into throat [foreign body in respiratory tract], bottom brush came out of the brush head [device breakage].Case description: consumer contacted via phone and stated that the bottom brush came out of the brush head.No serious injury was reported.

Event Description

Suffocated me [asphyxia] coughing - throat [cough] gagging - throat [retching] bottom brush fell into throat [foreign body in respiratory tract] bottom brush came out of the brush head [device breakage] product counterfeit [product counterfeit] consumer contacted via phone and stated that the bottom brush came out of the brush head.No serious injury was reported.

Manufacturer Narrative

25-jan-2019 product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.

• Brand Name: ORALBPWRPWRORALCARERFLSDUALACTNUNKBRUSHSET1CT
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 8270457
• MDR Text Key: 134063512
• Report Number: 3000302531-2019-00010
• 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
• Type of Report: Initial,Followup
• Report Date: 12/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• Patient Age: 81 YR