SLING UNIV HIGH SPACER LARGE 9153649442
Received Jul 14, 2016 · Event occurred Aug 15, 2014
Report 1525712-2016-02457 · MDR key 5793494
Product problems
- Torn Material
Patient
89
- Death
- Fall
- Death
- Fall
Narrative
Additional Manufacturer Narrative
NO PHOTOGRAPHS ARE AVAILABLE FOR INVESTIGATION. RETURN OF SLING FOR INVESTIGATION IS NOT ANTICIPATED; SLING WAS DESTROYED BY THE FACILITY. THE USER¿S MANUAL WARNS THAT AFTER EACH LAUNDERING, INSPECT SLING(S) FOR WEAR, TEARS, AND LOOSE STITCHING. BLEACHED, TORN, CUT, FRAYED, OR BROKEN SLINGS ARE UNSAFE AND COULD RESULT IN INJURY. DISCARD IMMEDIATELY. THERE IS INSUFFICIENT EVIDENCE TO COMPLETELY VERIFY THAT THE PRODUCT IS AN INVACARE DEVICE; MODEL AND SERIAL NUMBER ARE NOT AVAILABLE, AS IT WAS REPORTED THAT THE SLING WAS DESTROYED. BASED ON THE REPORT THAT THE FACILITY HAS VARIOUS RELIANT SLINGS AND THE SERIOUSNESS OF THE ALLEGATION OF DEATH, AN MDR WILL BE FILED AS UNKNOWN MANUFACTURER BY INVACARE TO (B)(6).
Description of Event or Problem
PER LEGAL DEPARTMENT, THE LAWYER REPRESENTING THE END USER ALLEGES IN (B)(6) 2014 THE END USER WAS BEING TRANSFERRED FROM THE WHEELCHAIR TO THE BED ON A RELIANT LIFT, NO MODEL OR SERIAL NUMBER WAS PROVIDED. LAWYER ALLEGES THE SLING TORE AND CAUSED THE END USER TO FALL AND HIT HER HEAD ON THE EDGE OF THE BED BOARD WITH ENOUGH FORCE TO BREAK THE END USERS NECK. LAWYER ALLEGES THE END USER EXPIRED SIX WEEK LATER LAWYER ALLEGES THE END USER WAS BEING TRANSFERRED BY NURSING HOME STAFF. UPDATE FROM CONSUMER AFFAIRS ON 06/24/2016: THE SLING WAS APPARENTLY DESTROYED, SO THE EXACT MODEL NUMBER/DATE CODE WILL NEVER BE CONFIRMED. HOWEVER, THE ALLEGATION IS THAT IT IS A RELIANT SERIES SLING. THE FACILITY PURCHASED VARIOUS RELIANT SLINGS FROM 2003-2014 AND EVEN THE OLDER ONES WERE STILL IN USE. THE LAWSUIT ALLEGES THAT THE SLING BROKE LOOSE AND SHE FELL OUT THE SIDE AND THE FALL ULTIMATELY LED TO HER DEATH.