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

Model Number 2872

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problems Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Event 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 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.

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
• Type of Device: MATTRESS, FLOATATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11970293
• MDR Text Key: 255366642
• Report Number: 0001831750-2021-00952
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 07613327424607
• UDI-Public: 07613327424607
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 2872
• Device Catalogue Number: 2872000011
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other