MAUDE Adverse Event Report: J. T. POSEY CO. PREMIUM HEEL GUARD

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 heel blister and a small deep tissue injury (dti).

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).

• Brand Name: PREMIUM HEEL GUARD
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: sokea peou ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4589049
• MDR Text Key: 5447112
• Report Number: 2020362-2015-00031
• 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
• Report Date: 02/02/2015

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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