FDA Adverse Event Other Summary report: N

EZ WAY SMART STAND

MDR report key: 5722824 · Received June 10, 2016

Report

Report Number
MW5062783
Event Type
Other
Date Received
June 10, 2016
Manufacturer
EZ WAY INC.
Product Code
IKX
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

PLEASE FIND THE ENCLOSED INFORMATION HELPFUL IN PRODUCT SAFETY FOR THOSE OF US WHO HAVE BUT LITTLE CHOICE IN THE FINAL VULNERABLE DAYS OF LIFE WHERE THE MOST MONEY IS SPENT IN TRYING TO HELP THOSE WHO ARE ILL AND UNABLE TO CARE FOR THEMSELVES. MY MOTHER (B)(6) WAS A CARE GIVER HER ENTIRE LIFE TO HER FAMILY AND HER ELDERLY DISABLED MOTHER WHOM SHE SPENT FEEDING HER LUNCH AND DINNER DAILY AT A NURSING FACILITY AFTER BREAKING HER HIP FOR 3 YEARS. MY FATHER, A HUSBAND WHOM WELCOMED HIS WIFES MOTHER FOR 13 YEARS INTO OUR HOME TO LIVE AND HAVE A HOME TO CALL HOME. WHILE FEEDING 12 FAMILY MEMBERS MORNING, NOON AND NIGHT WAS A DEDICATED MAN TO HIS ENTIRE FAMILY PASSING AWAY 25 YEARS AGO. WE ARE ALL AWARE OF THE VAST AMOUNT OF MONIES SPENT IN THE LAST YEAR OR TWO OF OUR LIVES. PRODUCT SAFETY SHOULD BE VALUED AS THE PORTAL OF ENTRY INTO THE AGED LIFESTYLE WHICH IS ON ALL OF OUR MINDS AS THE BABY BOOMERS OF (B)(6) ARE CLOSE TO THAT TIME OF LIFE. IF THIS IS A ROUTINE OPINION THAT THE INSURANCE COMPANIES KEEP THEIR MONIES AWAY FROM THOSE THAT HAVE BEEN INJURED BY THE EQUIPMENT THAT HAS BEEN DEEMED A PRODUCT LIABILITY IN INSPECTION AND OR MANUFACTURE THROUGH COMPLAINTS SUCH AS MINE THE USAGE OF THEIR DENIAL GOES RIGHT INTO THE POCKETS OF THE ADMINISTRATIVE INDIVIDUALS AS THEY DENY BLAME AND HAVE AN EXCUSE FOR EVERY ACTION THAT IS BROUGHT FORTH FOR INVESTIGATION WITH A RULING OF BLOWING OFF THE INJURED PARTIES. BLAMING THOSE THAT ARE INJURED FOR THE MISTAKES OF THE COMPANY'S FAULTS. TODAY'S WORKFORCE IS BY NO MEANS WHAT IT WAS WITH THE SINCERITY OF WHAT QUALITY AND WORKMANSHIP WAS MEANINGFUL AND TOOK PRIDE TO THE PEOPLE WHO SPENT THEIR LIVES AT A COMPANY IN THE PAST. OUR COUNTRY WAS BUILT ON THE BACKS OF PEOPLE WHO CARED ABOUT WHAT THEY WERE PRODUCING. DEDICATED TO THE STATE OF (B)(6) IN THE COMPLIANCE OF STATE AUTHORITY AND LICENSING WITH REGULATIONS FOR INSURANCE COMPANIES AND ITS AGENTS FOR THE PROTECTION OF THE PEOPLE WHO RESIDE AND COMMIT TO THE RULES OF HONESTY AND INTEGRITY HERE IN THE STATE OF (B)(6). AS A COMMUNITY MEMBER, I (B)(6) CONTACTED THE OFFICE OF ATTORNEY GENERAL (B)(4) AND STAFF WHICH HAVE RECOMMENDED THAT I FILE A COMPLAINT WITH THE (B)(4). OFFICE ALSO RECOMMENDED THAT I CONTACT THE (B)(4) IN REGARDS TO A CATASTROPHIC FAILURE OF A MEDICAL DEVICE USED IN THE TRANSPORTING OF A DISABLED INDIVIDUAL FROM CHAIR TO CHAIR INCLUDING TOILETING. MY MOTHER, (B)(6) HAD A STROKE (B)(6) 2011 WHICH RENDERED HER WITH RIGHT SIDE WEAKNESS AND THE INABILITY TO WALK OR TRANSFER HERSELF WHILE LIVING IN HER OWN HOME. AFTER SPENDING THREE MONTHS IN THERAPY AT (B)(6), WHEELCHAIRS COSTING (B)(4) THE DECISION TO PURCHASE THE (B)(4) SMART STAND WAS NEEDED TO REMAIN IN HER OWN HOME AS SHE WISHED TO DO SO. THE FAMILY FOUND A 24/7 COMPANION. THE FAMILY PURCHASED A CONVERSION VAN WHICH CAN COST UP TO $(B)(4) NEW, REMODELING HOMES LIKE BATHROOMS TO KEEP HER LIFE AS NORMAL AS POSSIBLE. CHURCH, GROCERY SHOPPING, ATTENDING HER FLOWER CLUB MEETINGS AND UP TO HER FAMILY CABIN THAT HER HUSBAND HAD PURCHASED IN THE 1960'S WITH A FAMILY OF NINE CHILDREN. WE PURCHASED THE (B)(4) LIGHT STAND MODE #11860, SERIAL #(B)(4), (B)(6) 2011 BEING USED AT (B)(6) A NON-PROFIT STATE ASSISTED ORGANIZATION FOR THE DISABLED. OUR FAMILY PAID $(B)(4) FOR SHIPPING, BUT WAS TOLD THAT THEY ALL WERE DELIVERED IN BOXES AND PUT TOGETHER BY TECHNICIANS. WE USED THE (B)(4). DEVICE FOR THREE AND ONE HALF YEARS (APPROXIMATELY 2215 DAYS) WITHOUT ISSUE. SHE SAW HER PRIMARY CARE PHYSICIAN YEARLY AND WAS IN GOOD HEALTH, ABLE TO RESIDE IN HER OWN HOME, STAYING CURRENT WITH (B)(4) ISSUES WATCHING THE NEWS NIGHTLY AND READING THE MORNING PAPER DAILY. SHE PARTICIPATED IN PREPARING HER OWN MEALS, WAS ABLE TO EAT AND DRINK LIQUIDS HOT OR COLD BY HERSELF AND PLAY NUMEROUS GAMES OF SCRABBLE AND CARDS WHICH SHE ENJOYED. ON (B)(6) 2015 A CATASTROPHIC FAILURE OF THE (B)(4) STAND BROKE INTO SEVERAL PIECES DURING THE TRANSFER OF (B)(6) AT WHICH TIME SHE HIT THE FLOOR WITH HER COCCYX BONE DAMAGING TISSUE AND NERVE AND BLOOD SUPPLY TO HER REAR. X-RAYS THAT DAY SHOWED NO BROKEN BONES AND THE COMPANY (B)(4) WAS CALLED. THEY SENT A NEW UNIT TO THE HOME (B)(6) 2015. AFTER FALLING, (B)(6) STOPPED EATING AND BECAME AGITATED AS AN INTERNAL ABCESS FORMED FROM THE FALL DUE TO HER INJURIES. HER TAIL BONE POPPED THROUGH SEVERAL DAYS PRIOR TO HER DEATH WHICH WAS ON (B)(6) 2015, 104 DAYS AFTER THE FAILURE OF THE (B)(6) STAND DROPPING HER BOTTOM TO THE FLOOR. (B)(4) AND ITS THIRD-PARTY ADMINISTRATOR, (B)(4) HAVE DONE NOTHING TO RESOLVE THIS MATTER. THERE HAS BEEN TWO CLAIMS EXAMINERS ASSIGNED TO THE CASE AND INSTEAD OF ADDRESSING OUR CONCERNS, THE REPRESENTATIVE (B)(4) WAS UNPROFESSIONAL AND QUESTIONED THE CARE THE FAMILY PROVIDED FOR OUR MOTHER ALONG WITH THE INTENSIVE QUESTIONING OF HOW WE WERE FINANCIALLY KEEPING OUR MOTHER IN HER HOME FOR SO LONG. SHE CUT HER CONVERSATION OFF WHEN SHE FOUND OUT THAT MY MOTHER'S HOME HAD BEEN REVERSED MORTGAGED AS SHE WAS UNDER HOSPICE CARE AFTER THE FAILURE OF THE MACHINE. ON (B)(6) 2015 THE PRESIDENT OF (B)(4) CONTACTED MYSELF AND DR. (B)(6) AT OUR HOME ON THE SPEAKER PHONE AND ACKNOWLEDGED LIABILITY, BUT A (B)(4) REPRESENTATIVE HAS NOW INFORMED US THAT THE COMPANY (B)(4) DENIES ADMITTING LIABILITY FOR THE DEFECTIVE PRODUCT. BOTH DR. (B)(6) AND MYSELF FEEL THAT (B)(4) SHOULD IMMEDIATELY CORRECT THIS ERROR IN MANUFACTURING FOR SAFETY ISSUES IN THE FUTURE FOR ANY VULNERABLE INDIVIDUAL WHO WOULD BE USING THIS PRODUCT WITHOUT THE SAFETY CORRECTIONS NEEDED TO PREVENT THE HORRIFIC PAIN AND SUFFERING MY MOTHER (B)(6) WENT THROUGH AFTER THEIR MACHINE FAILED CAUSING HER UNDENIABLE SUFFERING IN THE 104 DAYS UNTIL HER DEATH. THEY SHOULD BE MADE TO CORRECT THE PROBLEMS THIS PRODUCT COULD INFLICT WHICH IS CURRENTLY OUT ON THE MARKET AND IN MANY STATES FUNDED FACILITIES MOVING THE VULNERABLY DISABLED WHO HAVE NO VOICE. I HOPE THAT THE (B)(4) DEPARTMENT OF COMMERCE ALONG WITH (B)(4), CAN HELP PRESERVE THE LIVES OF THOSE WHO ARE UNFORTUNATE TO BE PLACED INTO SUCH A SITUATION THAT WOULD REQUIRE THE COMPLETE RELIANCE ON A MEDICAL DEVICE THAT AT THIS TIME IS NOT SAFE FOR USE. THE EXPERIENCE WAS UNBELIEVABLE AND UNCONSCIONABLE FOR A COMPANY TO DENY AND NOT PUT SAFETY FEATURES TO PREVENT A FAILURE AS GRUELING AS THE ONE MY MOTHER WAS PUT THROUGH ENDING IN HER PREMATURE DEATH WITH HER PAIN AND SUFFERING. ONE YEAR AGO IN THESE FOLLOWING CONCLUSIVE 104 DAYS STARTING ON (B)(6) 2015 AND ENDING ON (B)(6) 2015 AT 12:45 AM. THANK YOU ALL IN ADVANCE FOR YOUR ATTENTION TO THIS PROBLEM AND HOPEFULLY A SOLUTION WILL COME FROM THIS INFORMATION I HAVE BEEN REQUESTED TO PROVIDED. IT APPEARS THAT THE REASON FOR THE FAILURE OF THE LIFT WAS MISUSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
373453 EZ WAY SMART STAND LIGHT STAND IKX EZ WAY INC. 11860

Patients

Seq Age Sex Outcome Treatment
1