MAUDE Adverse Event Report: LIFEFACTORY SILICONE TEETHING RING; RING, TEETHING, FLUID-FILLED

Device Problems Crack (1135); Component Missing (2306)

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

Event Date 07/01/2019

Event Type  No Answer Provided  

Event Description

My son had been using this teething ring.When he twisted it around, i could see cracks in it.Upon inspecting it, i found one small piece of it is missing and there are cracks all around it.Light green, manufactured date: 11/2013.(b)(4).

• Brand Name: LIFEFACTORY SILICONE TEETHING RING
• Type of Device: RING, TEETHING, FLUID-FILLED
• MDR Report Key: 8922696
• MDR Text Key: 155690978
• Report Number: MW5089242
• Device Sequence Number: 1
• Product Code: KKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1