MATTRESS COVER FOR MEDICAL PURPOSES

Description of Event or Problem

(B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. RECEIVED A PHONE CALL FROM END USER'S DAUGHTER STATING IN THE PAST THEY PURCHASED A BED, MATTRESS AND THE PART ON TOP OF THE MATTRESS (PURCHASED 2ND HAND FROM SOMEONE WHOSE FAMILY MEMBER HAD EXPIRED) AND THAT IS THE AFFECTED PART THAT HAS CAUSED BED SORES TO HER MOTHER. MOTHER IS BEING TREATED BY WOUND CARE (NO FURTHER DETAILS). MDR FILED.

Additional Manufacturer Narrative

(B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED. INJURY ALLEGED.