MAUDE Adverse Event Report: POSEY PRODUCT LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2510

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer.Historical review found similar cases of patients being able to break out of the restraint.The cause was determined to be user error or a failure to follow the instructions for use (ifu) steps for application of the device, as well as use with the incorrect patient population for this device.The ifu contraindications state to not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self 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 warning 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 warrant.Manufacturer reference file (b)(4).

Event Description

On (b)(6) 2021 the customer contacted us via e-mail.The customer would like to report that they had a patient break out of their 2510 restraints.A nurse was kicked but no report of injury was filed to our knowledge.They do not have the restraint anymore to return for inspection as it was disposed of and is no longer available.

• Brand Name: LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 12181955
• MDR Text Key: 261981081
• Report Number: 2020362-2021-00039
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2021

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: No Information
• Device Model Number: 2510
• Device Catalogue Number: 2510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/16/2021
• 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