SLING UNIV HIGH SPACER LARGE 9153649442
Received Jan 4, 2016
Report 1525712-2015-05997 · MDR key 5339990
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED. USER¿S MANUAL REVIEW (1023891 REV. I, PAGE 6) AFTER EACH LAUNDERING (IN ACCORDANCE WITH INSTRUCTIONS ON THE SLING), 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. THE PRODUCT MANUFACTURER IS UNKNOWN. UNKNOWN IF SLING IS INVACARE OR PRO ACTIVE. INVACARE IS ONE OF THE POSSIBLE MANUFACTURERS SO INVACARE HAS CHOSEN TO FILE THE 3500A WITH THE FDA UNDER THE INVACARE CFN/FEI.
Description of Event or Problem
CALLER IS STATING THAT THE SLING BROKE AND HE IS INVESTIGATING THE FACILITY. CALLER HAS BEEN TOLD BY THE FACILITY THAT THE STRAP BROKE ON THE SLING, IT DETACHED WHERE IT ATTACHES. HE ALSO SAID THEY CANNOT FIND THE SLING AT THE FACILITY. HE KNOWS THE FACILITY USES BOTH INVACARE AND PRO ACTIVE SLINGS, NOT SURE WHAT SLING WAS BEING USED. HE KNOWS THE SLING WAS ORDERED IN (B)(6) 2014 AND FAILED (B)(6) 2015.