MAUDE Adverse Event Report: J.T. POSEY COMPANY PREMIUM HEEL GUARD; PROTECTOR, SKIN PRESSURE

Model Number 6145

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

Patient Problem Skin Erosion (2075)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Customer reported the patient had a skin breakdown and a small dti (deep tissue injury) area.

Event Description

Supplemental submission based on no product return evaluation.

Manufacturer Narrative

Conclusions: without the return of the product and/or images provided, the complaint could not be confirmed.Per report, the hospital checks once every shift at minimum, which does not meet the ifu specified to check at least every two hours.It is possible that this caused the reported additional occurrence with no details.Note: all complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.

Manufacturer Narrative

Product was requested to be returned to evaluation and has not been received.Note: this submission is based solely on the user facility's reported issue.Note: posey instructions for use warns the user to, "be sure to follow your facility¿s policies and guidelines for frequency of patient monitoring.Inspect the patient¿s leg at least every two hours to check for skin integrity, blood circulation and adequate allowance for movement of lower leg and foot.Inspect products before each use: check for broken stitches; or torn, cut or frayed material.Do not use soiled or damaged products.(b)(4).

• Brand Name: PREMIUM HEEL GUARD
• Type of Device: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): J.T. POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4573838
• MDR Text Key: 5556061
• Report Number: 2020362-2015-00035
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

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: Health Professional
• Device Model Number: 6145
• Device Catalogue Number: 6145
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other