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 Pressure Sores (2326)

Event Date 01/27/2020

Event Type  Injury  

Event Description

It was reported that a patient suffered pressure injuries on their abdomen.The wounds were treated with special wound dressings.The customer is not alleging the mattress caused or contributed directly to the injury.

Manufacturer Narrative

After investigation, the alleged pressure injury was most likely due to the patient lying belly down for an extended period of time with little movement due to their medical condition.The support surface was not alleged to have any defect or malfunction.A stryker field service representative attempted to evaluated the mattress, however the customer could not locate the unit.H3 other text : device not made available for evaluation.

Event Description

It was reported that a patient suffered pressure injuries on their abdomen.The wounds were treated with special wound dressings.The customer is not alleging the mattress caused or contributed directly to the injury.

• 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: 9717292
• MDR Text Key: 179920979
• Report Number: 0001831750-2020-00302
• 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: 07/07/2020

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: 02/05/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other