MAUDE Adverse Event Report: BANDAID; BANDAGE, ELASTIC

Lot Number 1155982A

Device Problem Use of Device Problem (1670)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Blister (4537)

Event Date 04/15/2023

Event Type  Injury  

Event Description

I was due for my aimovig injection and i cleaned the area out with alcohol wipe let it dry then squeezed my right thigh placed the injection, after the click i count to 5 then removed the pen and placed it in a sharps container.Then i placed a bandaid on my thigh.Later that evening it felt itchy and i noticed the redness.The next day it had bubbled up.Looked like hives, but then as the day went on, the more itchy it got and more bubbles filled with clear fluids.Sent message to my doctor and surgeon because i had surgery on monday the 10th of april.They both said to take a steroid to help with the reaction.Ref report: mw5116805.

• Brand Name: BANDAID
• Type of Device: BANDAGE, ELASTIC
• MDR Report Key: 16769803
• MDR Text Key: 313736588
• Report Number: MW5116806
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 1155982A
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AIMOVIG (ERENUMAB-AOOE) INJECTION; BIOTIN; CANDESARTAN; FOLIC ACID; JOLESSA
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Hispanic