MAUDE Adverse Event Report: COLGATE-PALMOLIVE COMPANY COLGATE TOOTHBRUSH; TOOTHBRUSH, MANUAL

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

Abrasive due to harsh bristle.This pack of toothbrushes from (b)(6) is not soft at all as the package says.They may be wrongly packed as soft.The bristles are too hard.

• Brand Name: COLGATE TOOTHBRUSH
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): COLGATE-PALMOLIVE COMPANY
• MDR Report Key: 11306999
• MDR Text Key: 231584790
• Report Number: MW5099299
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR