FDA Adverse Event Injury Summary report: N

SOFT FIT SUEDE FINISH WRIST BRACE

MDR report key: 6854760 · Received September 11, 2017

Report

Report Number
MW5072072
Event Type
Injury
Date Received
September 11, 2017
Date of Event
June 24, 2017
Report Date
September 7, 2017
Manufacturer
FLA ORTHOPEDICS / BSN MEDICAL GMBH
Product Code
ILH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THE PRODUCT IS A RIGHT WRIST SPLINT/BRACE. FLA ORTHOPEDICS 22-150SMBLK WRIST SPLINT L3908. I HAVE NO LOT NUMBER, THE MEDICAL SUPPLY COMPANY NEVER GAVE ME THE BOX TO THE PRODUCT. RECEIVED FRIDAY (B)(6) 2017. BY SATURDAY AFTERNOON, THE PAIN IN MY WRIST WAS INTENSE. IT FELT LIKE MY WRIST WAS BEING PULLED IN AN UNNATURAL POSITION. I REMOVED THE SPLINT AND IMMEDIATELY ICED MY WRIST. A FEW HOURS LATER, I TRIED THE BRACE AGAIN. THE SAME PAIN AND DISCOMFORT RETURNED. I ALSO HAD A LEFT SPLINT I HAD ORDERED BUT WASN'T CURRENTLY WEARING. I PUT THEM BOTH ON AND COMPARED THEM. THE RIGHT WRIST SUPPORT BAR WAS IN A COMPLETELY DIFFERENT POSITION THAN THE LEFT WRIST. THE LEFT WAS STRAIGHT FROM THE PALM OF MY HAND DOWN ON TO MY INNER FOREARM. THE RIGHT STARTED FROM THE SAME SPOT ON MY PALM BUT MOVED COMPLETELY TO THE LEFT SIDE OF MY INNER FOREARM. I HAVE PICTURES OF BOTH WRISTS WEARING THE SPLINTS SIDE BY SIDE FOR COMPARISON. I ALSO HAVE PICTURES OF BOTH LEFT AND RIGHT WRIST SIDE BY SIDE WITHOUT THE SPLINTS SHOWING THE SWELLING CAUSED BY THE DEFECTIVE SPLINT. I DO NOT HAVE THE DEFECTIVE SPLINT. IT WAS RETURNED TO THE MEDICAL SUPPLY COMPANY I PURCHASED IT FROM ON MONDAY (B)(6) 2017 RIGHT AFTER I CONTACTED THEM FIRST THING IN THE MORNING ABOUT IT. THEY LOOK NO ACTION, SHOWED NO CONCERN, AND OFFERED NO APOLOGY FOR THE PROBLEM. I CONTACTED THE MFR ABOUT THE ISSUE ON (B)(6) 2017. I RECEIVED A GENERAL RESPONSE FROM THEM ON (B)(6) 2017 THANKING ME FOR MY FEEDBACK AND TOLD SOMEONE WOULD BE CONTACTING ME ABOUT THE ISSUE. I HEARD BACK FROM THEIR RETURNS DEPARTMENT ON (B)(6) 2017. THEY CONTACTED THE MEDICAL SUPPLY COMPANY AND CONFIRMED THEY HAD IT. I NEVER HEARD FROM THEM AGAIN EVEN THOUGH THEY SAID THEY WOULD SEND ME A REPLACEMENT I'VE EMAILED THEM AGAIN AND GOTTEN NO RESPONSE. I DO NOT KNOW WHO CURRENTLY HAS IT. A REFILL FOR STEROIDS TO DEAL WITH THE PAIN AND SWELLING CAUSED WAS PICKED UP ON (B)(6) 2017.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
634454 SOFT FIT SUEDE FINISH WRIST BRACE SPLINT, HAND AND COMPONENTS ILH FLA ORTHOPEDICS / BSN MEDICAL GMBH 22-150SMBLK

Patients

Seq Age Sex Outcome Treatment
1 43 YR Other