InjuryINE
FULL BODY W/COMMODE MESH XLRG 9153632099
Received Jan 22, 2016
Report 1531186-2016-00002 · MDR key 5385759
Device
Product problems
- Break
- Device Operates Differently Than Expected
- Break
- Device Operates Differently Than Expected
Patient
Not reported
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or Problem
THE FACILITY REP STATES THE SLING CAME APART WHERE THE HANDLE ATTACHES TO THE SLING. THE FACILITY REP STATES THERE WAS A CONSUMER IN THE SLING, AND THE END USER FELL OUT OF THE SLING AND WAS INJURED. THE REP STATES THE END USER HAD A LACERATION TO HIS RIGHT SHOULDER AND HAD TO RECEIVE STITCHES AT THE ER. UPDATE FROM 01/15/2016 ADDED BY CONSUMER AFFAIRS: SLING HAS BEEN SET UP TO RETURN AND HAS BEEN REPLACED. NO LOT NUMBER ON THE TAG AVAILABLE. END USER RECEIVED MEDICAL TREATMENT AND IS IN GOOD CONDITION. NO FURTHER INFORMATION WILL BE PROVIDED DUE TO HIPAA.