MAUDE Adverse Event Report: J. T. POSEY CO. POSEY DELUXE PODUS BOOT; IQI

Model Number 6148

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

Patient Problem Ulceration (2116)

Event Type  Injury  

Event Description

Customer reported the patient has ulcers after using the podus boot.Although the issue was found during the use the exact date of event is unk.

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.Note: this submission is based solely on the user facility's reported issue.Additional info has been requested and response confirmed that the info is currently being gathered.(b)(4).

• Brand Name: POSEY DELUXE PODUS BOOT
• Type of Device: IQI
• Manufacturer (Section D): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: sokea peou, qe analyst ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4431996
• MDR Text Key: 5395686
• Report Number: 2020362-2015-00004
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/18/2014

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: 6148
• Device Catalogue Number: 6148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AMBULATION SOLE, 6148ML
• Patient Outcome(s): Required Intervention