MOLNLYCKE Z-FLEX

Description of Event or Problem

WE RECEIVED A REPORT OF A PATIENT DEVELOPING DEEP TISSUE INJURIES (DTIS) WHILE THE DEVICE WAS BEING USED AS INTENDED TO HELP REDUCE THE RISK OF PRESSURE RELATED INJURIES. ACCORDING TO THE REPORTER, THE AFFECTED PATIENT DEVELOPED LOCALIZED AREAS OF DISCOLORATION AND TISSUE BREAKDOWN CONSISTENT WITH SUSPECTED DTIS. THE DTIS WERE IDENTIFIED DURING ROUTINE CLINICAL ASSESSMENT. AT THE TIME OF REPORTING, LIMITED CLINICAL DETAILS WERE AVAILABLE REGARDING THE EXACT ONSET, PROGRESSION, AND CONTRIBUTING MEDICAL CONDITIONS. NO DEFINITIVE DEVICE MALFUNCTION HAS BEEN CONFIRMED. HOWEVER, BECAUSE DTIS REPRESENT A SERIOUS INJURY AND THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE INJURY DURING NORMAL USE, THIS EVENT MEETS THE CRITERIA FOR REPORTING UNDER 21 CFR PART 803. AN INVESTIGATION HAS BEEN INITIATED. WE ARE CONDUCTING A REVIEW OF DEVICE HISTORY RECORDS, COMPLAINT TRENDS, RISK MANAGEMENT DOCUMENTATION, AND ANY AVAILABLE PRODUCT RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPORTER TO CLARIFY THE CLINICAL CIRCUMSTANCES, DEVICE USAGE CONDITIONS, AND ANY POTENTIAL CONFOUNDING PATIENT FACTORS (E.G., COMORBIDITIES, MOBILITY STATUS, OFF LOADING PRACTICES). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL MDR REPORTS WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.