MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number UNK_MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 11/30/2023

Event Type  Injury  

Event Description

It was reported that a patient acquired a pressure injury.Attempts are being made to gather additional injury and treatment details from the user facility.The device is currently pending evaluation and the model and serial number have not yet been provided.

Event Description

It was reported that a patient acquired a pressure injury.

Manufacturer Narrative

As a result of this alleged event, a stryker sr qae spoke with the inpatient wound care coordinator, who described the patient as high acuity and at high risk of developing a pressure injury.It was further stated that the pressure injury was classified as a deep tissue injury and that there was no malfunction of the surface.Rather, the surface wasn't appropriate for the needs of this patient and that the staff should have used a different surface to treat this patient.There are a number of different factors that contribute to pressure injuries, such as nutrition, skin condition, moisture and pressure injury treatment protocol.Given that all factors that are within stryker¿s control were evaluated and found to be operating as intended, it was determined that there were no defects found with the surface that would have potentially caused or contributed to the alleged pressure injuries.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18351913
• MDR Text Key: 330816182
• Report Number: 0001831750-2023-01366
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other