MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED

Catalog Number UNK_MED

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

Patient Problem Pressure Sores (2326)

Event Date 11/24/2023

Event Type  Injury  

Event Description

It was reported that a patient suffered a pressure sore.There was no product malfunction alleged.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

It was reported that a patient suffered from pressure sores.There was no malfunction of the product alleged by the customer.In response to the alleged injury, a stryker sales representative reached out to the customer on 11/30/2023, 12/6/2023, and 1/26/2024 for further information about the product malfunction and the injuries the patient suffered.However, the customer failed to provide any further information.After investigation, the cause for the alleged issue of pressure sores (to patient) could not be confirmed as a stryker representative was not able to evaluate the unit.The customer failed to provide any information on the alleged malfunction of the product or specific details of injury suffered by the patient.The issue was resolved for the customer by confirming that no further action is required from stryker.

Event Description

It was reported that a patient suffered a pressure sore.There was no product malfunction alleged.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, PATIENT ROTATION, 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18257734
• MDR Text Key: 329619868
• Report Number: 0001831750-2023-01355
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: 11/24/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 11/24/2023
• Supplement Dates FDA Received: 03/06/2024
• 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