MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. MULTI-SPECIALTY POSITIONING KT, W/ARM PADS & LIFT SHEET; SUPPORT, PATIENT POSITION

Model Number	M60-SF505
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "we had a patient that slid on the bed today using the black pad.Her legs were straight, and she was a very tiny girl.Is there a weight limit as to maybe she was too small and that's why she slid." deroyal industries requested return of the device, but it was not available.A supplier corrective action request (scar) was sent to the supplier.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Event or Problem Description
A user facility reported, "we had a patient that slid on the bed today using the black pad.Her legs were straight, and she was a very tiny girl.Is there a weight limit as to maybe she was too small and that's why she slid".
Additional Manufacturer Narrative
Deroyal industries requested return of the device, but it was not available.A supplier corrective action request (scar) was sent to the supplier.However, it was determined that this was not a supplier issue and the scar was rescinded.The complaint reported a slide and asked if there was a weight limit with the device.The ifu and pamphlet from the deroyal website states that this product should not be used on patients over 500 pounds.There is no lower weight limit.Further information was gathered from the sales manager of the reporting customer.It was found that patient moved about 8-12 inches on the pad.The customer also stated that they did have to move the patient around a good bit at the beginning of the procedure and stated that they thought that might have been when she had moved.The customer also confirmed that after they reset her position she stayed there the rest of the procedure with no further movement issues.Because no lot number was provided, no work order could be reviewed for the manufacturing process.Deroyal did review labeling and the failure modes and effects analysis for the product and no issues were found.No inventory was on hand at deroyal to be inspected.A complaint to sales ratio was conducted over the past two years and found to be 0.22%.Root cause: because the sample was not able to be returned and no lot number was provided, the investigation able to be performed was limited.With the limited information and no issues found with the investigation able to be performed, no root cause was able to be determined.Potential root cause: based on additional conversations with the customer and the sales manager, there is a potential that this issue could have been a user error.However, without more information, this could not be confirmed.Corrective and preventive actions: because no root cause was able to be determined, no corrective or preventive actions were taken.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: MULTI-SPECIALTY POSITIONING KT, W/ARM PADS & LIFT SHEET
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21424550
• Report Number: 1043214-2025-00001
• Device Sequence Number: 20778870
• Product Code: CCX
• UDI-Device Identifier: 00749756390248
• UDI-Public: 00749756390248
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M60-SF505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown