FDA Adverse Event Injury Summary report: N

ARC INSTATEMP NON-TOUCH THERMOMETER

MDR report key: 6471705 · Received April 6, 2017

Report

Report Number
MW5068976
Event Type
Injury
Date Received
April 6, 2017
Date of Event
April 4, 2017
Report Date
April 6, 2017
Manufacturer
ARC DEVICES
Product Code
FLL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

WHEN WE WENT TO PICK MY (B)(6) OUT OF HER CRIB THE MORNING OF (B)(6) 2017, THERE WAS DEBRIS ALL OVER HER ROOM FROM A THERMOMETER THAT EXPLODED IN HER ROOM WHILE SHE WAS SLEEPING. ALL OF THE PIECES WERE MOSTLY FOUND ON THE FLOOR AROUND HER CRIB AND ON TOP OF A NEARBY BOOKSHELF, BUT THERE WAS ASH IN THE CRIB, ON TOP OF ITS SIDES, AND ON A NEARBY GLIDER AS WELL. IT WAS VERY UPSETTING THAT THERE WAS EXPLODED MATERIAL ALL OVER MY BABY'S CRIB AND NURSERY WHILE SHE WAS IN THERE SLEEPING. I HAVE PICTURES AND A VIDEO I TOOK WITH MY CELL PHONE. THIS IS THE THERMOMETER - HTTP://(B)(6)/P/ARC-INSTATEMP-NON-TOUCH.../-/A-21481167. I CALLED THE MANUFACTURER, ARC DEVICES, ON (B)(6) 2017. THE PERSON I SPOKE WITH, (B)(6), ASKED ME TO EMAIL THEM PICTURES AND ASKED THAT I SHIP THE PARTS BACK TO THEM FOR INVESTIGATION. THEY SAID THEY WOULD EMAIL ME SHIPPING LABEL TO SEND THE THERMOMETER PIECES TO THEM, BUT I DID NOT RECEIVE AN EMAIL FROM THEM. I DECLINED THEIR OFFER FOR A REPLACEMENT. I PURCHASED IT FROM (B)(6) A FEW WEEKS AGO. I CALLED THE (B)(6) IN (B)(6), WHERE I PURCHASED THE PRODUCT, ON (B)(6) 2017. THE MANAGER I SPOKE WITH, (B)(6), SAID THEY WOULD FILL OUT AN INCIDENT REPORT AND REMOVE THE PRODUCT FROM THE SHELVES IN THE STORE UNTIL THEY RECEIVE WORD FROM THE MANUFACTURER THAT IT IS OK TO SELL. THE PRODUCT WAS ON DISPLAY IN THE INFANT SECTION OF THE STORE. THEY DID NOT ASK FOR ANY OF MY CONTACT INFORMATION OR TO SEE PICTURES OF THE PRODUCT. I HAD TESTED THE THERMOMETER TO MAKE SURE IT WORKED AFTER I HAD PURCHASED IT, BUT OTHER THAN THAT DID NOT USE IT. I USUALLY KEEP IT IN MY DAUGHTER'S CLOSET IN A CONFINED AREA WHERE THIS EXPLOSION COULD HAVE BEEN WORSE. I HAD THE THERMOMETER IN A SPOT WHERE I COULD EASILY FIND IT IN THE MIDDLE OF THE NIGHT BECAUSE SHE WENT TO SLEEP THAT NIGHT FEELING SICK WITH A COLD. I WANTED TO SPREAD THE WORD SO HOPEFULLY NO ONE WHO HAD THIS DEVICE GETS HURT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
251173 ARC INSTATEMP NON-TOUCH THERMOMETER ARC INSTATEMP NON-TOUCH THERMOMETER FLL ARC DEVICES PT-100312-CF1

Patients

Seq Age Sex Outcome Treatment
1 13 MO OTC MEDS: NONE| RX MEDS: NONE