MAUDE Adverse Event Report: POSEY PRODUCTS LLC FOOT ELEVATOR; PROTECTOR, SKIN PRESSURE

Model Number 6533

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The customer could not be reached to facilitate return of the device.This event is reported solely on the information provided by the customer.A historical review of the complaint database found two (2) other complaints of this product causing or contributing to bed sores.Of the two, there was only one for which the unit was returned for evaluation.It was determined that the unit met specifications.The instruction for use indicates to reduce pressure on the ankle and hypertension of the knee, a pillow may be placed under the patient¿s knee and leg.Additionally, the instruction for use states that this product recommends to be removed at least every two (2) hours to check for skin integrity, proper circulation, and range of motion.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.Manufacturer reference file # (b)(4).

Event Description

Customer reported per (b)(6) that this product was suppose to help her mom instead it created bed sores on her legs etc.The date the issue was discovered is unknown.

• Brand Name: FOOT ELEVATOR
• Type of Device: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8696740
• MDR Text Key: 147924390
• Report Number: 2020362-2019-00149
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/13/2019
• 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
• Patient Outcome(s): Required Intervention