MAUDE Adverse Event Report: ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20; TOOTHBRUSH, POWERED

Model Number EB20

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Pain (1994)

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

Lips get hurt [lip pain].Head has become detached, the metal pin comes out - oral-b [device breakage].Causing a gap - oral-b [device physical property issue].Consumer via e-mail stated that their brush head became detached, causing a gap in which the lips got hurt.Also, the metal pin comes out.No serious injury was reported.

Event Description

Lips get hurt [lip pain] head has become detached, the metal pin comes out - oral-b [device breakage] causing a gap - oral-b [device physical property issue] product counterfeit [product counterfeit] consumer via e-mail stated that their brush head became detached, causing a gap in which the lips got hurt.Also, the metal pin comes out.No serious injury was reported.

Manufacturer Narrative

(b)(6) 2021 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: ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20
• Type of Device: TOOTHBRUSH, POWERED
• MDR Report Key: 12187645
• MDR Text Key: 264266412
• Report Number: 3000302531-2021-00250
• 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: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EB20
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Date Manufacturer Received: 08/19/2021
• 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
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN