MAUDE Adverse Event Report: LUV N' CARE LTD. NUBY; RING, TEETHING, FLUID-FILLED

Device Problem Corroded (1131)

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

Event Date 06/01/2018

Event Type  No Answer Provided  

Event Description

I bought a vibrating teether for my son, after only 3 days of using it, it stopped vibrating.I opened up the back where the battery is to see if the battery maybe gotten moved, and it was full of corrosion.This is very unsafe for a baby to chew on.Incident location: (b)(6), united states; this is my home address.Retailer: (b)(6); retailer state: (b)(4); purchase date: (b)(6) 2018.Document number: (b)(4).Report number: (b)(4).

• Brand Name: NUBY
• Type of Device: RING, TEETHING, FLUID-FILLED
• Manufacturer (Section D): LUV N' CARE LTD.
• MDR Report Key: 7663470
• MDR Text Key: 113311324
• Report Number: MW5078239
• 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
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1