MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD CURAD BAND FLEX FAB 3/4" X3"; TAPE AND BANDAGE, ADHESIVE

Model Number CUR47315RR

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

Pt reports they had a reaction like a burn to the curad bandage flex "fab" 3/4" by 3" (ndc: 00000047372/ lot number unk) so they will try the gentle silicone bandage instead.Date unknown but per pharmacy system the product was last dispensed on (b)(6) 2023.Unknown if pt has had a reaction like this before or if this is a new allergy.Unknown if prescriber is aware.No further info, details or dates available.Pt reports no hereditary angioedema attacks since their last fill.Haegarda dosing and frequency: inject 7000 units (14 ml) under the skin 2 times a week (every 3 to 4 days).Consent to contact the patient's hcp was not asked.All known information is contained on this form.Reported to (b)(6) by pt/caregiver.

• Brand Name: CURAD BAND FLEX FAB 3/4" X3"
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 16683545
• MDR Text Key: 312857417
• Report Number: MW5116317
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2023

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?: Yes
• Device Model Number: CUR47315RR
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Patient Sequence Number: 1
• Patient Sex: Female