MAUDE Adverse Event Report: SILICONE BABY TEETHING TOY INFANT RATTLING TEETHER SOOTHING PANDAMELON ; RING, TEETHING, NON-FLUID FILLED

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2020
Event or Problem Description
On (b)(6) 2020, there is a little white bait with a hole at the bottom.There is a plastic round ball about the size of a marble and the consumer said that her husband was able to pop the ball out.Therefore, it could be a choking hazard.The baby was chewing on the toy, but was not injured.The diameter of the ball popped out is slightly larger than a dime, but smaller than a nickel.The consumer called (b)(6) and reported her concerns.The rep told her that they would notify the seller.The consumer contacted the fda, because she claims that the product was fda approved.The fda said that they don't approve toys and referred her to cpsc.Retailer: (b)(6).(b)(4).

• Brand Name: SILICONE BABY TEETHING TOY INFANT RATTLING TEETHER SOOTHING PANDAMELON
• Common Device Name: RING, TEETHING, NON-FLUID FILLED
• MDR Report Key: 9877805
• Report Number: MW5093921
• Device Sequence Number: 2483399
• Product Code: MEF
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1