MAUDE Adverse Event Report: STRYKER ISOGEL AIR BED; COVER, MATTRESS (MEDICAL PURPOSES)

Device Problems Contamination (1120); Delamination (2904)

Patient Problem No Information (3190)

Event Date 05/04/2018

Event Type  malfunction  

Event Description

Mattress covers are delaminating and breaking down on the underside allowing fluids to enter the body of the mattress leading to potential risk of patient exposure.

• Brand Name: ISOGEL AIR BED
• Type of Device: COVER, MATTRESS (MEDICAL PURPOSES)
• Manufacturer (Section D): STRYKER; 3800 e. centre ave.; MI 49002
• MDR Report Key: 7518133
• MDR Text Key: 108556226
• Report Number: MW5077237
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other