MAUDE Adverse Event Report: JT POSEY COMPANY FOAM LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2532

Device Problem Escape (2931)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product was requested to be returned but was not received for evaluation.This report is based solely on the customer's reported issue.Since the actual device was not returned and there is not enough information about how the patient was able to escape, the reported issue could not be confirmed.A dhr review could not be performed since there was no lot number provided for this device.Stock samples were tested and when applied according to the instructions for use the restraint functioned as intended.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.The instructions for use contain directions on applying the device.Additionally, a label on the device itself advises users to twist the buckle before inserting to prevent the strap from loosening.Following these instructions should prevent loosening of the product.A warning is provided that additional or different body or limb restraints may be needed if a patient pulls violently against the bed straps and/or to reduce the risk of the patient getting access to the line, wound or tube site.Facilities should always monitor patients per facility policy.Manufacturer reference file # (b)(4).Device not available.

Event Description

Customer reported a patient was able to escape from the wrist cuff and extubate himself.The date the issue was discovered is unknown and there was no serious injury reported.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): JT POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6080613
• MDR Text Key: 59225436
• Report Number: 2020362-2016-00044
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• 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