MAUDE Adverse Event Report: J. T. POSEY CO. 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 pt had a bilateral breakdown on the outside of the foot and a small deep tissue injury (dti).

Event Description

Supplemental based on no product return evaluation.

Manufacturer Narrative

Product was requested to be returned for eval and has not been received.This submission is based solely on the user facility's reported issue.(b)(4).

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 bilateral breakdown on the outside of the foot and small deep tissue issue.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.

• Brand Name: PREMIUM HEEL GUARD
• Type of Device: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: sokea peou ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4589027
• MDR Text Key: 5479663
• Report Number: 2020362-2015-00033
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 03/10/2015
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other