MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. BODY BELT; RESTRAINT, PROTECTIVE

Model Number M1018-U

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Choking (2464)

Event Date 12/18/2023

Event Type  Injury  

Event Description

The patient had waist restraint choke them where nurse was not able to release restraint with quick release buckle.Had to cut strap to release choking hazard.

Manufacturer Narrative

A complaint was received on 12/18/2023 reporting the patient had waist restraint choke them where nurse was not able to release restraint with quick release buckle.Had to cut strap to release choking hazard.The actual sample was not returned to deroyal for evaluation.A video was sent to demonstrate how the product attaches to the customers beds.The instructions for use states do not use on a patient who is or may become highly aggressive or agitated.The root cause was determined to be improper product selection by the customer.The product did not work correctly with their specific beds the buckle was getting stuck at the anchor point when trying to release.It was determined to be no actual issue with the design of the product.The sales representative recommended a similar product that would work best with the customers beds.Due to the root cause 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: BODY BELT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3 finca morancito; villa canales, 01065, guatemala ; GT
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3 finca morancito; villa canales, 01065, guatemala ; GT
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 18495698
• MDR Text Key: 332726564
• Report Number: 3010452421-2023-00017
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 00749756162494
• UDI-Public: 00749756162494
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

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 Model Number: M1018-U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening