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

Model Number 2860

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Discoloration (2074)

Event Date 03/26/2020

Event Type  Injury  

Event 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.

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 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
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 9923282
• MDR Text Key: 186394320
• Report Number: 0001831750-2020-00316
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 07613327278514
• UDI-Public: 07613327278514
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 2860
• Device Catalogue Number: 2860000026
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other