MAUDE Adverse Event Report: E.M. ADAMS CO., INC. E.M ADAMS CO, INC.; RESTRAINT, PROTECTIVE

Model Number	26-0692
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was able to break both soft wrist restraints away from the bed and self extubated despite interventions of bedside rn and respiratory therapist.

• Brand Name: E.M ADAMS CO, INC.
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): E.M. ADAMS CO., INC.; 7496 commercial circle; fort pierce FL 34951
• MDR Report Key: 21468415
• Report Number: 21468415
• Device Sequence Number: 3492226
• Product Code: FMQ
• UDI-Device Identifier: 10840200304242
• UDI-Public: (01)10840200304242
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/23/2025
• Report Date (Section F): 01/23/2025

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: 26-0692
• Device Catalogue Number: 26-0647
• Device Lot Number: 11-24
• 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: 02/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2025
• 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
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Date Report Sent to FDA: 01/23/2025