MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX W BX 80 OPT CVR INTL; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number	2860
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patients are experiencing skin redness after laying on the isoflex mattresses.No further information has been provided at this time.
Additional Manufacturer Narrative
It was originally reported that the severity and treatment of the pressure injuries was unknown.Additional information has been provided by the user facility and section b5 has been updated to reflect this.The user facility was not able to identify the serial numbers involved in order to have the devices evaluated.User facility was unable to locate the device for evaluation.
Event or Problem Description
It was reported that patients are experiencing skin redness after laying on the isoflex mattresses.The user facility stated that the patients were experiencing reactive hyperemia, which is a minor pressure related injury that disappears after some time.

• Brand Name: ISOFLEX W BX 80 OPT CVR INTL
• Common Device Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 9923282
• Report Number: 0001831750-2020-00316
• Device Sequence Number: 16968188
• Product Code: IKY
• UDI-Device Identifier: 07613327278514
• UDI-Public: 07613327278514
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 2860
• Device Catalogue Number: 2860000026
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other