MAUDE Adverse Event Report: RANIR LLC CORE VALUES BR HDS SMSNC PRO 3PK; TOOTHBRUSH, POWERED

Model Number BR HDS SMSNC PRO 3PK

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Event Description

Consumer purchased harmon replacement toothbrush heads for her phillips toothbrush and alleges that the head "catapulted off of the phillips toothbrush and cracked her teeth and she felt pieces of tooth in her mouth." requested product from claim handler who retrieved it from the store.

• Brand Name: CORE VALUES BR HDS SMSNC PRO 3PK
• Type of Device: TOOTHBRUSH, POWERED
• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 9088609
• MDR Text Key: 163573896
• Report Number: 1825660-2019-00617
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS SMSNC PRO 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/20/2019
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/19/2019
• 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