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

Catalog Number 2510

Device Problems Inadequate Instructions for Healthcare Professional (1319); Patient Device Interaction Problem (4001)

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

Event Date 09/19/2020

Event Type  malfunction  

Event Description

Nurse caring for critical intubated patient heard banging of the patient's bed.Nurse found that patient had broken the left soft wrist holder and was in the process of reaching his hand toward ett tube.New limb holder was applied and patient was not successful with self extubation.There was no injury to patient or team members.Follow up: this was the correct product for the patient population per the instructions for use.The correct device was used for the type of bed being used.We have been using posey limb holders for a long period of time.Applicable team members have received training on this product.The ifu was followed ensuring that the force is around the wrist and not the foam of the product.The limb holder was correctly applied.The customer was large and very strong.

• Brand Name: POSEY ECONOMY LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 10585847
• MDR Text Key: 208525358
• Report Number: 10585847
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Weight: 124