MAUDE Adverse Event Report: POSEY PRODUCTS LLC LOCKING TWICE-AS-TOUGH CUFFS WRIST; RESTRAINT, PROTECTIVE

Model Number 2792

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation codes: the customer declined to return the product.The customer indicated that a video of the reported event would be provided for investigation, but this video has not yet been received.This report is based on the customer's alleged issue that the device can be made to fail if pulled on a specific way.Historical data did not reveal any similar events and the instructions for use (ifu) provide adequate instructions and warnings for safe and effective use of the device.The ifu states "before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch; cracked or broken buckles or locks; and/or that hook-and-loop adheres securely, as these may allow patient to remove cuff.Discard if device is damaged." note: the ifu instructs the user to "press the hook-and-loop closure together firmly and make sure it adheres securely.Slide one finger (flat) between the cuff and the inside of the patient¿s wrist to ensure proper fit.The cuffs must be snug enough to prevent escape, but not interfere with circulation.Check to ensure that: bed attachment straps cannot slide in any direction, tighten or loosen if the patient pulls on them, or if the bed is adjusted; cuffs are attached in a way that the patient is not able to use his or her teeth or otherwise remove the device; cuffs are intact, and not torn or damaged.Do not allow patients to ingest product material." (b)(4).

Event Description

Customer reported the patient was able to pull on the securing strap with her mouth and exit the restraint.The patient was being monitored at the time of the event and no patient or caregiver injuries occurred.This particular patient has required restraints multiple times while in the hospital.Per report, when the securing strap is pulled on, the d-rings allegedly criss-cross and come undone.The securing strap is no longer secured and the patient is able to access the strap that connects to the side of the velcro to open the wrist device.The date the issue was discovered is unknown and not patient injuries were reported.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS WRIST
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6852975
• MDR Text Key: 85793756
• Report Number: 2020362-2017-00023
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2792
• Device Catalogue Number: 2792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1