MAUDE Adverse Event Report: STRYKER MEDICAL ISOTOUR MATTRESS COVER; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 2872

Patient Problem Unspecified Infection (1930)

Event Date 04/08/2024

Event Type  Injury  

Event Description

Mattress covers recently have been experiencing unexpected tears, making the surface uncleanable.This is an issue because patient bodily fluids can get through the cover, and onto the mattress itself.Being an uncleanable surface, the risk for the spread of infection is increased from patient to patient.Replacement covers have been ordered, but will not arrive for the immediate replacement of the amount of necessary mattress covers experiencing this unexpected issue.

• Brand Name: ISOTOUR MATTRESS COVER
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL
• MDR Report Key: 19097284
• MDR Text Key: 340167937
• Report Number: MW5153796
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention