MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 84IN W OPTION CVR; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number	2860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a hospital acquired pressure injury that was found by a wocn.The pressure injury was unstageable and reported as a deep tissue pressure injury.The injury was described as a straight line across the sacral region.The patient was discharged and no additional medical treatment was required for hospital acquired pressure injury that they know of.
Additional Manufacturer Narrative
The customer reported that the nursing staff checked the patient for pressure injuries 3 days and 9 days after the procedure.The deep tissue pressure injury was found 9 days after the spine procedure.The gel compression set of the internal gel was measured to be within the tolerance as provided in the operations/maintenance manual.As the gel was within performance specifications identified in the manual, the alleged surface contributing to a patient acquiring an unstageable deep tissue pressure injury was not due to any component level defect of the product.
Event or Problem Description
It was reported that the patient had a hospital acquired pressure injury that was found by a wocn.The pressure injury was unstageable and reported as a deep tissue pressure injury.The injury was described as a straight line across the sacral region.The patient was discharged and no additional medical treatment was required for hospital acquired pressure injury that they know of.
Additional Manufacturer Narrative
It was originally reported that the device was evaluated.Requests were made to physically evaluate the surface.However, the customer did not make the product available for further evaluation.Images of the device were evaluated and no component level defects were visibly identifiable.H3 other text : device was not accessible for testing.
Event or Problem Description
It was reported that allegedly a patient experienced a hospital acquired pressure injury (hapi) following a spine surgery while on an isoflex lal surface described as unstageable/deep tissue pressure injury in the sacral region.Additionally, it was provided that the patient had a known small pressure injury prior to the spine procedure in a different location than the acquired deep tissue pressure injury.The customer reported that the wound consult nurse checked the patient for pressure injuries 3 days and 9 days after the procedure.The deep tissue pressure injury (hapi) was found 9 days after the spine procedure and reportedly did not require any additional medical treatment before the patient was discharged.

• Brand Name: ISOFLEX LAL 84IN W OPTION CVR
• Common Device Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14270491
• Report Number: 0001831750-2022-00567
• Device Sequence Number: 5842879
• Product Code: IKY
• UDI-Device Identifier: 07613327278507
• UDI-Public: 07613327278507
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 03/10/2023

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 Model Number: 2860
• Device Catalogue Number: 2860000019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 04/06/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 11/22/2022; 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2018
• 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