MEBB CHIC SENSORY CHEW NECKLACE B07DXM357C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for MEBB CHIC SENSORY CHEW NECKLACE B07DXM357C manufactured by Unknown.

Event Text Entries

[138087607] I purchased sensory chew necklace set, (8 pack) from (b)(6). This type of product is designed for children to chew on. We have previously purchased products like this and had no trouble. These products immediately started crumbling when the child chewed them. Our (b)(6) year old just spit them out when they came apart, but i worry about smaller children ingesting or possibly choking on them. The manufacturer seems to know about this problem, because in their (b)(6) store listing they write: " no reason to refund? : our brand mebb chic sensory chew necklace are made from food grade silicone, not too soft and not to hard, just perfect for chew. However, some kids are able to chew up. Don't worry, we offer a risk free trial, contact with us to get a full refund if the sensory chew necklace were broken. " silicone chewy sticks for autistic, adhd, oral motor boys and girls children; blue,red, yellow, orange. Mebb chic is a company which concentrate on baby teething products, such as baby teething necklace, baby teething pacifier clip, and silicone baby teether toys. All of the baby teething products are made from 100% food grade silicone, fda cpsc/cpsia, approved. Bpa free, metals free, phthalate free, toxic pvc free, lead free, 100 % ensure safety for your baby use. I contacted (b)(6) for a refund, and tried to tell them that the product was unsafe. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084705
MDR Report Key8396575
Date Received2019-03-06
Date of Report2019-02-08
Date of Event2019-02-06
Date Added to Maude2019-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEBB CHIC SENSORY CHEW NECKLACE
Generic NameRING, TEETHING, NON-FLUID FILLED
Product CodeMEF
Date Received2019-03-06
Model NumberB07DXM357C
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.