FDA Adverse Event Other Summary report: N

GEL HEAT PACK; 21 INCHES BY 16 INCHES

MDR report key: 5462881 · Received February 24, 2016

Report

Report Number
MW5060518
Event Type
Other
Date Received
February 24, 2016
Date of Event
January 3, 2016
Report Date
January 6, 2016
Manufacturer
PALM NRG
Product Code
IMD
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE CONSUMER RECEIVED THE GEL PACK AS A CHRISTMAS GIFT. THE CONSUMER STATES HER DAUGHTER PURCHASED THE GEL PACK FROM A KIOSK STAND IN (B)(6). ON (B)(6) 2016, THE CONSUMER PRESSED THE BUTTONS ON THE GEL PACK TO ACTIVATE THE HEAT. AFTER A FEW MINUTES, WHEN THE CONSUMER NOTICED THE ENTIRE GEL PACK GOT WARM SHE PLACED IT ON HER NECK AND SHOULDERS FOR ABOUT 30 MINUTES. THE CONSUMER STATES SHE TOOK IT OFF BECAUSE THE GEL PACK GOT HARD. AFTER TWO HOURS THE CONSUMER NOTICED THAT HER NECK AND SHOULDERS, WHERE THE GEL PACK WAS PLACED, WAS RED AND THERE WERE SPOTS (WHERE THE BUTTONS TOUCHED HER SKIN). THE CONSUMER STATES SHE DID NOT FEEL PAIN OR DISCOMFORT. THE CONSUMER STATES SHE INSPECTED THE GEL PACK TO SEE IF THERE WAS A HOLE WHERE THE GEL COULD HAVE LEAKED BUT SHE DID NOT NOTICE ANY DAMAGE TO THE GEL PACK. THE CONSUMER WAITED 2 HOURS AND THEN WENT TO THE ER AT (B)(6) HOSPITAL, (B)(6). THE CONSUMER WAS ADVISED BY THE DOCTOR THAT THE BLOOD VESSELS IN HER NECK AND SHOULDERS WERE BURNED FROM THE GEL PACK. THE CONSUMER STATES SHE HAS CALLED THE FIRM ((B)(4) ON THREE OCCASIONS AND SHE INFORMED EACH REP (NAME UNKNOWN) SHE SPOKE TO ABOUT THE INCIDENT BUT EACH REP ASSURED HER THE GEL PACK COULD NOT HAVE BURNED HER. THE CONSUMER WAS ALSO ADVISED THAT SHE WOULD NEED TO RETURN THE GEL BACK TO THE PLACE OF PURCHASE BECAUSE THEY COULD NOT ASSIST HER. THE CONSUMER STATES HER NECK AND SHOULDERS ARE STILL RED AND THE SPOTS ARE STILL VISIBLE. INJURY, ER TREATMENT RECEIVED. PURCHASE DATE: (B)(6) 2015. HOME ADDRESS: (B)(6). DOCUMENT (B)(4). PURCHASE DATE: (B)(6) 2015. MFR # (B)(4). COLOR OF GEL PACK: BLUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
113527 GEL HEAT PACK; 21 INCHES BY 16 INCHES GEL HEAT PACK; 21 INCHES BY 16 INCHES IMD PALM NRG REPEAT THE HEAT

Patients

Seq Age Sex Outcome Treatment
1 51 YR