MAUDE Adverse Event Report: TRUE BALTIC AMBER BALTIC AMBER TEETHING NECKLACES/BRACELETS; RING, TEETHING, NON-FLUID FILLED

Health Effect - Clinical Code	Strangulation (2084)
Date of Event	04/11/2021
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2021 we lost our sweet (b)(6) due to being strangled by a teething necklace that she was wearing.(b)(6) was (b)(6) old and bear crawled everywhere.Evidently, she crawled under her walker and it was caught on something as she flipped over.It strangled her to death.Fda safety report id# (b)(4).

• Brand Name: BALTIC AMBER TEETHING NECKLACES/BRACELETS
• Common Device Name: RING, TEETHING, NON-FLUID FILLED
• Manufacturer (Section D): TRUE BALTIC AMBER ; ganyklu g. 18; palanga 00126 ; LH 00126
• MDR Report Key: 11818572
• Report Number: MW5101333
• Device Sequence Number: 11324053
• Product Code: MEF
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 8 MO