MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; RESTRAINT, PROTECTIVE

Model Number	M7035-S
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On [redacted], the pediatric patient had the elbow positioner/immobilizer in place on the patient's left arm in order to provide protection for the intravenous picc [peripherally inserted central catheter] line and dressing.While repositioning the patient, the nurse noted that the metal rod had dislodged from the cloth covering and was digging into the patient's underarm causing a puncture wound.(there was also an earlier report of the same product also dislodging from the cloth covering but no injury was noted with that first one - that product was also discarded).The patient's left axilla injury site assessed by the pediatric surgery nurse practitioner, cleansed with normal saline and packed with a wick dressing and mepilex applied.Daily wound care provided.

• Brand Name: DEROYAL
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 23849852
• Report Number: 23849852
• Device Sequence Number: 9526855
• Product Code: FMQ
• UDI-Device Identifier: 00749756113427
• UDI-Public: 00749756113427
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/03/2025
• Report Date (Section F): 12/04/2025

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
• Device Model Number: M7035-S
• Device Catalogue Number: M7035-S
• Device Lot Number: 62098955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/04/2025