MAUDE Adverse Event Report: GELOCAST UNNA BOOT; BANDAGE, ELASTIC

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 01/25/2021

Event Type  Injury  

Event Description

Patient was prescribed unna boot compression treatment at previous visit.Patient was wrapped at whi in primer unna boot which is dr.(b)(6) preferred brand.Home health went out to the patient between whi visits and wrapped the patient in the (b)(6) unna boot.It has been discussed previously with home health that dr.(b)(6) does not approve of the (b)(6) brand of unna boot because the percentages of medications are not equivalent.Patient arrived for physician visit this morning wrapped in the (b)(6) unna boot with skin deterioration and allergic reaction to the product.Fda safety report id # (b)(4).

• Brand Name: GELOCAST UNNA BOOT
• Type of Device: BANDAGE, ELASTIC
• MDR Report Key: 11273446
• MDR Text Key: 230693244
• Report Number: MW5099204
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): Y
• 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

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR