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	Pressure Sore/Ulcer (2326)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 9717292
• Report Number: 0001831750-2020-00302
• Device Sequence Number: 10853090
• 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): 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
• Operator of Device: No Information
• Device Model Number: 2860
• Device Catalogue Number: 2860000026
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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