MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 INCH,STD, END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number	2872000012
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gel sections on the device are separating.It was further reported that the patient has a worsening pressure injury.Additional attempts are being made to obtain more information.
Additional Manufacturer Narrative
It was reported by the customer that the gel sections on the device are separating, resulting in a worsening pressure injury for the patient.Based on previous trending complaints, a stryker qae identified that the alleged surface sagging, too soft, or not firm enough was most likely due to detached/disconnected surface internal gel.Multiple attempts have been made to gather the serial number, injury information, and treatment information, with no response received.Should a response be received, this complaint may be reopened and updated accordingly.
Event or Problem Description
It was reported that the gel sections on the device are separating.It was further reported that the patient has a worsening pressure injury.
Event or Problem Description
It was reported that the gel sections on the device are separating.It was further reported that the patient has a worsening pressure injury.
Additional Manufacturer Narrative
It was reported by the customer that the gel sections on the device are separating, resulting in a worsening pressure injury.Based on previous trending complaints, a stryker qae identified that the alleged surface sagging, too soft, or not firm enough was most likely due to detached/disconnected surface internal gel.Multiple attempts have been made to gather the serial number, injury information, and treatment information, with no response received.Should a response be received, this complaint may be reopened and updated accordingly.

• Brand Name: ISOTOUR, 84 INCH,STD, END406
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 20161596
• Report Number: 0001831750-2024-01066
• Device Sequence Number: 7291747
• Product Code: FNM
• UDI-Device Identifier: 07613327424638
• UDI-Public: 07613327424638
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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?: Yes
• Device Catalogue Number: 2872000012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 08/22/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/31/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown