TEETHING BRACELET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for TEETHING BRACELET manufactured by The Little Biting Tree.

Event Text Entries

[111328453] I handed my (b)(6) son the teething bracelet to hold while i changed his diaper. He put it into his mouth and it broke apart, with many wooden beads about the size of blueberries filling his mouth. He choked and i quickly picked him up, turned him over, and patted his back vigorously. Beads came out and i held him upright and he kept choking. I yelled for my mother in law to call 911. I repeated the procedure also finger sweeping at one point. Beads kept coming out and he kept choking. I kept repeating and he threw up. He was breathing when the paramedics arrived but they sent us to er to be sure all beads were out. He was created and checked out ok. It was terrifying and i thought he was going to die. The website said not to give to baby alone and it was intended for an adult to wear, however showed a picture of a baby chewing it and called it a teething bracelet that was double strung. We contacted seller asking her to warn other parents and not call it a teething bracelet. Purchase date: (b)(6) 2018. This date is an estimate.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077862
• MDR Report Key: 7605065
• Date Received: 2018-06-11
• Date Added to Maude: 2018-06-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TEETHING BRACELET
• Generic Name: RING, TEETHING, NON-FLUID FILLED
• Product Code: MEF
• Date Received: 2018-06-11
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE LITTLE BITING TREE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-06-11