FDA Adverse Event Malfunction Summary report: N

NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE

MDR report key: 8497230 · Received April 8, 2019

Report

Report Number
MW5085707
Event Type
Malfunction
Date Received
April 8, 2019
Date of Event
February 4, 2019
Report Date
March 6, 2019
Manufacturer
UNKNOWN
Product Code
KKO
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
283220 NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE RING, TEETHING, FLUID-FILLED KKO UNKNOWN
283221 NUBY SOOTHING TEETHER NUBY ICY BITE HAND, BLUE RING, TEETHING, FLUID-FILLED KKO UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 6 MO