MAUDE Adverse Event Report: RANIR LLC DM EF II HD; TOOTHBRUSH, MANUAL

Model Number EF II HD ASY BULK TRAY RD - DM

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2020

Event Type  malfunction  

Event Description

Consumer stated that while he/she was using the brush head it felt very strange when cleaning."then i noticed that a piece of metal, firmly anchored, looks out of the back." based on the pictures received, it appears to be an exposed staple.

• Brand Name: DM EF II HD
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 6166988880
• MDR Report Key: 9998495
• MDR Text Key: 189500929
• Report Number: 1825660-2020-00752
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EF II HD ASY BULK TRAY RD - DM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/27/2020
• Date Manufacturer Received: 03/27/2020
• 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