MAUDE Adverse Event Report: POSEY PRODUCTS, LLC POSEY ECONOMY LIMB HOLDER; RESTRAINT, PROTECTIVE

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2020

Event Type  malfunction  

Event Description

Patient with traumatic brain injury had bilateral soft wrist restraints applied to prevent pulling at life sustaining tubes/lines.Nurse reported that the patient was agitated and ripped through the "economy limb holder." the ring that holds the strap ripped off of the restraint allowing the patient to pull out an iv.The nurse was near to the patient at the time and was able to reach the patient before the patient could self-extubate.The iv was reinserted with no harm to the patient.The wrist restraint was bagged up and sent to the quality department.

• Brand Name: POSEY ECONOMY LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 272 east deerpath road suite 206; lake forest IL 60045
• MDR Report Key: 10167029
• MDR Text Key: 195553476
• Report Number: 10167029
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020,06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA