MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LOCKING LIMB HOLDER, ANKLE; RESTRAINT, PROTECTIVE

Model Number MDT829099A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Event Description

Staff went to apply the locking limb holder to the patient's left ankle.When adjusting the strap through the locking mechanism, a piece of the lock broke free from the spot weld and the restraint was not longer able to be applied effectively.This placed staff at risk for injury due to patient movement and potentially hitting the patient.In addition, if the restraint would have been placed, the lock would have broken with patient movement providing a metal object free within the patient room.Fda safety report id# (b)(4).

• Brand Name: LOCKING LIMB HOLDER, ANKLE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10301676
• MDR Text Key: 199916389
• Report Number: MW5095625
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2020

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 Operator: Health Professional
• Device Model Number: MDT829099A
• Device Lot Number: 33019070001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 86