MAUDE Adverse Event Report: UNKNOWN NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE; RING, TEETHING, FLUID-FILLED

Device Problems Device Emits Odor (1425); Material Opacification (1426); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

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).

• Brand Name: NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE
• Type of Device: RING, TEETHING, FLUID-FILLED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8497230
• MDR Text Key: 141602883
• Report Number: MW5085707
• Device Sequence Number: 1
• Product Code: KKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 MO