MAUDE Adverse Event Report: UNKNOWN BANDAGE; APPLICATOR, ABSORBENT TIPPED, STERILE

Patient Problem Skin Discoloration (2074)

Event Date 09/21/2023

Event Type  Injury  

Event Description

I received a flu vaccine on (b)(6) 2023 through my employer.The nurse applied a bandage which i kept on for 2-3 days (definitely no more than 3.I know that's more than needed but i just didn't think to peel it off).I still have a light mark on my arm in the shape of the adhesive.It's been 4 months now and i haven't noticed a change (although honestly, my upper left arm isn't a spot i look at often, especially as we've gone into cooler weather).It's like a lighter colored bandage tattoo.I reached out to the nurse to find out what brand bandage it may be to see if i could report directly to the manufacturer but was told that they use a variety of brands and she wasn't sure what was used that day, and to reach out to my primary care physician about it.I did not because it's not irritating and not worth it to me to pay for a primary care physician visit outside of my annual for some discoloration.I vaguely remember noting that my arm was a bit more irritated (itchier) after the vaccine when i had never had a reaction like that to the flu vaccine before, but it wasn't anything severe that made me question it.I'm now wondering if it could've been irritation from the bandage adhesive? i don't have any allergies that i'm aware of (besides seasonal), and this is the first time i've had any kind of reaction to a bandage or adhesive.

• Brand Name: BANDAGE
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18589984
• MDR Text Key: 333957677
• Report Number: MW5150795
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: VENLAFAXINE (GENERIC EFFEXOR).; VESTURA (BIRTH CONTROL).
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White