FDA Adverse Event Injury Summary report: N

FUTURO WRIST DELUXE STABILIZER ADJ ADJUSTABLE SIZE LEFT

MDR report key: 17406055 · Received July 25, 2023

Report

Report Number
MW5120161
Event Type
Injury
Date Received
July 25, 2023
Date of Event
July 22, 2023
Report Date
July 23, 2023
Manufacturer
3M COMPANY
Product Code
ILH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I PURCHASED A NEW SET OF WRIST BRACES, THE SAME BRAND AND STYLE THAT I ALWAYS GET FROM TARGET. THEY ARE 3M FUTURO DELUXE WRIST STAALIZER BRACES FOR WRIST PAIN, SUPPORT, AND CARPAL TUNNEL. I WAS REPLACING MY ORIGINAL ONES THAT I PURCHASED A FEW MONTHS AGO. THE NEW ONES HAVE BEEN REDESIGNED SO POORLY THAT THEY CAUSE EXCRUCIATING PAIN. THE THICKNESS AROUND THE THUMB AREA IS NOW GREATLY ENLARGED CAUSING THE BRACE TO PULL VERY HARD ON THE KNUCKLE JOINT AT THE INDEX FINGER. IT HAPPENS ON BOTH THE LEFT AND RIGHT SIDE VERSIONS OF THE BRACE. THIS CAUSES THE JOINT TO BE PULLED INCORRECTLY CAUSING SEVERE STRAIN ON IT, AGGRAVATION OF ARTHRITIS, TRIGGER FINGER, AND SWELLING IN THE FINGER THAT RADIATES DOWN INTO THE THUMB AND PALM AND THEN INTO THE WRIST AND FOREARM. THIS REDESIGN HAS CAUSED SEVERE PAIN AND EVEN THOUGH I ONLY WORE IT FOR ABOUT 10 MINUTES, MY FINGER HAD TO HAVE A MANUAL INTERVENTION TO LOOSEN THE MUSCLE THERE AND RESTORE FUNCTIONALITY AGAIN BY REDUCING PAIN AND INCREASED SWELLING THAT HAPPENED IN THE JOINT DUE TO THE TRIGGER OF AN INFLAMMATORY PROCESS CAUSED BY THE NEWLY REDESIGNED BRACES. THE METAL BAR ALONG THE PALM IS ALSO INCORRECTLY PLACED CAUSING PAIN AND PROBLEMS DUE TO ITS LOCATION. IT MAKES THE WRIST HURT BECAUSE THE PLACEMENT IS NOW OFF AND CAUSES MORE SWELLING AND PROBLEMS THAN IT ALLEVIATES. MY HAND IS STILL NOT OK EVEN A DAY LATER SINCE WEARING THIS BRACE FOR ONLY 10 MINUTES. IT WAS A DIRECT REPLACEMENT FOR MY CURRENT ONES THAT WERE THE SAME NUMBER AND EVERYTHING. THE MAIN DIFFERENCE I NOTED WAS THAT ON THE YELLOW TAG ON THE BAND NOW INSTEAD OF SAYING ADJ KT THEY NOW SAY ADJ EE. I AM GUESSING THIS IS THE NEW SERIES FOR THEM. EITHER WAY, IT'S TERRIBLE AND THEY ARE PUTTING THEM OUT AS IF THEY'RE THE SAME PRODUCT AND THEY'RE NOT. MY LOCAL STORE STOPPED SELLING THEM BECAUSE THEY ARE CONSTANTLY RETURNED NOW AND PATIENTS HAVE BEEN COMPLAINING ABOUT SEVERE PAIN FROM THEM ESPECIALLY IN THE THUMB AND INDEX FINGER. THEY NEVER USED TO BE RETURNED BEFORE THE REDESIGN. NOW EVERY SINGLE ONE THEY SOLD WAS RETURNED. I SPOKE WITH A FEW PHARMACISTS WHO ALSO SAID THESE ARE NO LONGER RECOMMENDED BECAUSE OF THE REDESIGN THAT HAS BEEN CAUSING PATIENTS SIGNIFICANT PROBLEMS AND EVEN INJURIES. IT MAKES SENSE. THE NERVES IN MY WRIST ARE NOW SO AGGRAVATED THAT NOTHING IS HELPING THEM. I DID NOTHING DIFFERENT THAN I WOULD HAVE WITH THE ORIGINALS. I ALSO TRIED THEIR ACE BANDAGE COUNTERPART, AND IT WAS THE SAME ISSUE THERE TOO. SAME PRODUCT WITH A DIFFERENT LABEL AND CAUSING THE SAME PAINFUL ISSUES NOW. THE INCIDENT OCCURRED LESS THAN 24 HOURS AGO, NOW THE PAIN IS SHOOTING ALL THE WAY UP TO MY ELBOW TODAY AND UNTIL I WORE THIS BRACE IT NEVER WENT THAT FAR UP. I AM TERRIFIED THIS MAY BE PERMANENT NOW THANKS TO THIS BRACE REDESIGN. THINKING MAYBE IT WAS JUST AN ISSUE WITH ONE OF THE NEW BRACES SUCH AS A DEFECT, I REPURCHASED A SECOND SET THAT CAUSED THE SAME PROBLEMS. THE ISSUE RESIDES IN THIS REDESIGN. THE REDESIGNED THUMB AREA ALONGSIDE THE ENTIRE REDESIGN OF THE BRACE ITSELF CAUSES MAJOR PROBLEMS. MY DOCTOR DOESN'T EVEN RECOMMEND THEM ANYMORE BECAUSE OF THE AMOUNT OF PATIENTS THAT HAVE BEEN PUT INTO SEVERE PAIN BY THESE BRACES NOW. OVER 5 SETS WERE COMPARED IN STORE AS COMPARED TO THE ORIGINAL ON BOTH THE LEFT AND RIGHT HAND SIDE AND FOUND TO BE COMPLETELY POORLY REDESIGNED CAUSING THE SAME PROBLEMS AMONG ALL THE NEWLY REDESIGNED VERSIONS AS COMPARED TO THE ORIGINALS WHICH DID NOT CAUSE ANY PROBLEMS FOR THE WEARER. REF REPORTS: MW5120162, MW5120163, MW5120164.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2325553 FUTURO WRIST DELUXE STABILIZER ADJ ADJUSTABLE SIZE LEFT SPLINT, HAND, AND COMPONENTS ILH 3M COMPANY 09013ENR 23096SQ

Patients

Seq Age Sex Outcome Treatment
1 30 YR Male Required Intervention| O| S ALLEGRA| CANE| CITALOPRAM| DEXEDRINE| LAMOTRIGINE| LOW DOSE NALTREXONE COMPOUNDED FOR CHRONIC PAIN| NASACORT | PROAIR