MAUDE Adverse Event Report: UNNA BOOT (PRIMER BRAND); BANDAGE, ELASTIC

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

Patient Problems Irritation (1941); Discharge (2225)

Event Date 01/28/2021

Event Type  Injury  

Event Description

Home health has been using the mckesson unna boot on patient since her last visit.Her last dressing change by home health was on monday (b)(6) 2021.Patient arrived at whi for scheduled md visit today (b)(6) 2021.Both legs were red and had massive drainage.Pictures are scanned into the patient media.Called and spoke with teka, home health nurse to verify brand used.Teka was provided primer unna boots yesterday for the patient's next dressing change.Fda safety report id # (b)(4).

• Brand Name: UNNA BOOT (PRIMER BRAND)
• Type of Device: BANDAGE, ELASTIC
• MDR Report Key: 11273421
• MDR Text Key: 230710744
• Report Number: MW5099203
• Device Sequence Number: 1
• Product Code: FQM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/01/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR