FDA Adverse Event Injury Summary report: N

FUTURO (TM) SPORT ADJUSTABLE WRIST SUPPORT

MDR report key: 3926314 · Received July 1, 2014

Report

Report Number
2110898-2014-00050
Event Type
Injury
Date Received
July 1, 2014
Date of Event
June 27, 2014
Report Date
June 27, 2014
Manufacturer
WINNING INDUSTRIAL CO. LTD.
Product Code
IQI
Report Source
Manufacturer report
Reporter Location
MT, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

HE SAID HE PUT THIS BRACE ON LAST THURSDAY, (B)(6). HE WORE IT ALL DAY AND THEN REMOVED IT THAT NIGHT. EVERYTHING LOOKED FINE. ON THE MORNING OF (B)(6) THE SKIN THAT HAD BEEN COVERED BY THE BRACE HAD WHAT LOOKED LIKE MANY LITTLE MOSQUITO BITES. HE PUT A BENADRYL GEL ON IT BUT IT CONTINUED TO GET WORSE AND DEVELOPED BLISTERS. BY THE MORNING OF (B)(6) THE BLISTERS HAD GROWN TO DIME SIZE AND THERE WAS A STRONG BURNING SENSATION. IT WAS A SATURDAY SO HE WENT FOR MEDICAL HELP. HE FIRST SAID HE WENT TO THE EMERGENCY ROOM, THEN HE SAID, "OR THE HOSPITAL, WHATEVER IT'S CALLED. THIS IS A REAL SMALL TOWN." HE SAW DR (B)(6) AND SHE GAVE HIM A SHOT. HE DOESN'T KNOWN WHAT IT WAS. THEN SHE PRESCRIBED METHYLPREDNISOLONE TABLETS. HE'S BEEN TAKING THOSE FOR CLOSE TO TWO DAYS NOW AND IT'S STARTING TO GET BETTER, ALTHOUGH NOT TOTALLY CLEARED UP YET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
383048 FUTURO (TM) SPORT ADJUSTABLE WRIST SUPPORT 890.3475 LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO. LTD. NA NA

Patients

Seq Age Sex Outcome Treatment
1 UNK