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

Model Number 2532

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Product was requested to be returned and has not been received for evaluation.This report is based solely on the information provided by the customer.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).No product returned at this time.

Event Description

Customer reported while the limb holder was in use with a patient the quick release buckle broke.The date the issue was discovered is unknown and no serious injuries were reported.

Manufacturer Narrative

Additional notes were provided by the customer.Customer confirmed there were no complaint against this product and no malfunction had occurred.Manufacturer reference file # (b)(4).

Event Description

Supplemental required for additional information.

Manufacturer Narrative

Correction, customer confirmed of a product malfunction.Stated patient was being weaned from sedation and was expected to become agitated when awaken.Facility had 3 people at the bedside when patient woke up and broke free of his restraint.Patient did not extubate or harm himself.Customer also confirmed that she will be returning the product back to the manufacturer.The product has not been received in or analyzed yet.Manufacturer reference file # (b)(4).

Event Description

Correction to provide event details.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey products llc; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6936738
• MDR Text Key: 90155125
• Report Number: 2020362-2017-00075
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• 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