FDA Adverse Event Malfunction Summary report: N

HYBERBYTE

MDR report key: 11321559 · Received February 11, 2021

Report

Report Number
MW5099361
Event Type
Malfunction
Date Received
February 11, 2021
Date of Event
February 8, 2021
Report Date
February 9, 2021
Manufacturer
STRAIGHT SMILE, LLC
Product Code
OYH
UDI-DI
00852673007127
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
HI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I RECENTLY BEGAN USING THE BYTE ALIGNERS FOR MY TEETH. PART OF THE TREATMENT INCLUDES THEIR PROPRIETARY AND 'FDA CLEARED' HYBERBYTE DEVICE. IT COMES WITH MICRO A USB CHARGING PORT AND CABLE TO CHARGE AND POWER IT. THE DEVICE INDICATOR LIGHT ALERTED ME THAT IT NEEDED TO BE CHARGED YESTERDAY, SO I PLUGGED IT INTO A DEDICATED USB CHARGING PORT ON ONE OF MY USB HUBS, AND A COUPLE OF HOURS LATER, WHEN I RETURNED FOR IT, I NOTICED A BURNING ELECTRICAL SMELL. I WASN'T SURE WHERE IT WAS COMING FROM UNTIL I PICKED UP THE HYBERBYTE, WHICH I IMMEDIATELY DROPPED, BECAUSE IT WAS BURNING HOT. TOO HOT TO HOLD. I THEN SAW IT HAD BROWN SCORCH MARKS AROUND WHERE THE MICRO USB CABLE SEATS INTO THE DEVICE, THERE WAS MELTED AND BUBBLING PLASTIC, AND THE CABLE END WAS BURNED AND CRACKED. I IMMEDIATELY PULLED THE USB CABLE LOOSE FROM THE OTHER END, WHERE IT WAS ATTACHED TO MY HUB. (THE HUB WAS AND IS FINE, STILL SUPPORTING OTHER CONNECTED DEVICES, AND THE HUB END OF THE CONNECTING CABLE WAS PERFECTLY COOL - THE HEAT WAS COMING FROM THE HYBERBYTE, SO I CAN ONLY ASSUME WHATEVER WAS SHORTING IS IN THERE) THE BURNED END OF THE CABLE NOW APPEARS TO BE PERMANENTLY FUSED TO THE MICRO USB PORT IN/ON THE DEVICE. I'M WRITING TO YOU, BECAUSE THIS DEVICE WAS SITTING ON MY DESK, NEAR PAPER, AND I FEEL LUCKY I DIDN'T END UP WITH A FIRE. ALSO, THIS IS A DEVICE I'VE BEEN TRUSTING AND OPERATING IN MY MOUTH FOR THE LAST FOUR WEEKS. (I JUST STARTED THE TREATMENT ONLY FOUR WEEKS AGO) LASTLY, I'M WRITING TO YOU BECAUSE WHEN I GOT SOMEONE FROM CUSTOMER SERVICE AT BYTE TO CALL ME BACK, THEY DIDN'T SOUND REMOTELY SURPRISED. THE CSR DIDN'T ASK ANY QUESTIONS, JUST SAID, "YEAH, YOU OBVIOUSLY LEFT IT PLUGGED IN TOO LONG." IT WAS ONLY PLUGGED IN FOR A COUPLE OF HOURS, WHICH SEEMS LIKE BARELY A NORMAL AMOUNT OF TIME TO RE-CHARGE ANY USB POWERED DEVICE, PLUS, THERE IS NOTHING IN THEIR DOCUMENTATION THAT SAYS LEAVING IT PLUGGED IN, EVEN AS MUCH AS OVERNIGHT, (WHICH ALSO FEELS NORMAL FOR RE-CHARGING A USB DEVICE) WOULD, SHOULD OR COULD BE A POTENTIAL PROBLEM. THEY SAID THEY WOULD REPLACE THE UNIT (NOT THE DESTROYED CHARGING CABLES THAT I ALSO PAID FOR BUT THAT'S MY PROBLEM, NOT YOURS) BUT THEY WANT ME TO SEND THEM THE DEFECTIVE AND DAMAGED UNIT IMMEDIATELY. I'D PREFER TO SEND THE UNIT TO SOMEONE LIKE YOU FOR EVALUATION, SO I WON'T BE RETURNING IT TO THEM IMMEDIATELY, BUT I ALSO OBVIOUSLY UNDERSTAND THE FDA IS DEALING WITH SOME CRAZIER AND MUCH MORE IMPORTANT BUSINESS OF LATE. IT SEEMED WORTH REPORTING THIS TO YOU THOUGH. BYTE LOUDLY AND OFTEN TOUTS THEIR 'FDA CLEARED' HYBERBYTE IN THEIR MARKETING AND ADVERTISING. IF THAT DEVICE IS SHORTING, AND CARRIES ENOUGH JUICE TO MELT AND BURN WHAT I SAW AND FELT, THEN A SMALL FIRE SEEMS LIKE IT MIGHT NOT BE THE WORST THING THAT COULD HAPPEN. AGAIN, THIS IS A DEVICE THAT I (AND OTHER BYTE USERS) PLACE IN OUR MOUTHS TO OPERATE FOR A MINIMUM 5 MINUTES DAILY, PER BYTE'S RECOMMENDATIONS. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
214404 HYBERBYTE ORTHODONTIC VIBRATORY ACCESSORY OYH STRAIGHT SMILE, LLC PRT-10217 REV C 121820-00005 00852673007127

Patients

Seq Age Sex Outcome Treatment
1