NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE manufactured by Unknown.

Event Text Entries

[141602883] We bought nuby soothing teether for our (b)(6). The teether was purchased around (b)(6) 2018. In (b)(6) i noticed that it feels sticky, it smells like ultrasound gel, and it's not full anymore. Upon closer examination, and trying to detect a leak, i noticed opaque debris dispersed inside the gel (those were not air bubbles). To me, they looked just like bacterial colonies would look like inside the petri dish. I contacted the manufacturer, and after seeing the pictures, they requested the item to be sent back for closer examination. I was also told that the teether is filled with poly acrylamide gel. I recently contacted the manufacturer to find out the results, and was informed that the quality control team "did not see any debris". They did agree though, that the teether was not full, but no leaks were detected. When everybody i showed the item to can see the "debris" and quality control team of the manufacturer can not, that just seems disingenuous and concerning that they may be withholding the information. Recently, while visiting physical therapist office, my baby was given nuby teether to play (the key chain). I noticed that the keys were half full and smelled like ultrasound gel. It seems to me that the plastic of those teethers is permeable/semipermeable and gel seeps out or evaporates over time. If the plastic is permeable, that means bacteria can possibly get inside and grow as well. Another concern is the gel itself that seeps out. The manufacturer did not address the opaque floating objects in their report and is claiming that qc team did not see the debris. Retailer: either (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085707
MDR Report Key8497230
Date Received2019-04-08
Date of Report2019-03-06
Date of Event2019-02-04
Date Added to Maude2019-04-09
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 Sequence Number: 1

Brand NameNUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE
Generic NameRING, TEETHING, FLUID-FILLED
Product CodeKKO
Date Received2019-04-08
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN

Device Sequence Number: 2

Brand NameNUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE
Generic NameRING, TEETHING, FLUID-FILLED
Product CodeKKO
Date Received2019-04-08
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-08

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