MAUDE Adverse Event Report: POSEY COMPANY POSEY; TWICE AS TOUGH CUFFS - KEY LOCK

Model Number 2799

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/07/2018

Event Type  Injury  

Event Description

Psychiatric pt placed in restraints for violent behavior.Restraints detached and were noted to come unsewn releasing the restraint from the bed allowing pt to become free of the restraint.

• Brand Name: POSEY
• Type of Device: TWICE AS TOUGH CUFFS - KEY LOCK
• Manufacturer (Section D): POSEY COMPANY; 5635 pek road; arcadia CA 91006 0020
• MDR Report Key: 7428428
• MDR Text Key: 105562554
• Report Number: MW5076464
• Device Sequence Number: 1
• Product Code: OYS
• 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: 03/28/2018

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: 2799
• Device Lot Number: 6242T038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 28 YR