MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOTOUR, 84 IN,PREMIUM END406; MATTRESS, FLOATATION THERAPY, NON-POWERED

Model Number	2872
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient sustained a deep tissue injury while using the isotour surface.Additional information regarding the pressure injury has been requested from the user facility.
Event or Problem Description
It was reported that a patient sustained a deep tissue injury while using the isotour surface.Further investigation identified that the isotour surface had not malfunctioned and had not contributed to the alleged injury in any way.
Additional Manufacturer Narrative
The completed investigation identified that the stryker product did not cause or contribute to the alleged injury.

• Brand Name: ISOTOUR, 84 IN,PREMIUM END406
• Common Device Name: MATTRESS, FLOATATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11970293
• Report Number: 0001831750-2021-00952
• Device Sequence Number: 17062380
• Product Code: IKY
• UDI-Device Identifier: 07613327424607
• UDI-Public: 07613327424607
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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
• Operator of Device: No Information
• Device Model Number: 2872
• Device Catalogue Number: 2872000011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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