MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY SAFETY VEST; RESTRAINT, PROTECTIVE

Catalog Number 3050XL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

Young male patient with behavioral issues in a roll vest to maintain safety, patient impulsive and sits up in bed, pushes self up, pulling at lines.Patient had aggressive attempts to get out of bed during outbursts of agitation throughout the night.Patient ripped the seam of the vest restraint.Nurse was present in a room and heard a ripping noise.Knowing they had a patient in next room in restraints, the nurse asked another to go check on the patient.Patient managed to rip only a small area before staff intervened.No injuries or other issues noted.Restraint was applied on admission date (2 days prior to event).

• Brand Name: POSEY SAFETY VEST
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 272 east deerpath road suite 206; lake forest IL 60045
• MDR Report Key: 11677621
• MDR Text Key: 245808258
• Report Number: 11677621
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3050XL
• Device Lot Number: 1026T030
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Weight: 26