MAUDE Adverse Event Report: INJECTION SAFETY INDUSTRIES LLC. BARRIER BANDAGE; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 04/15/2022

Event Type  Injury  

Event Description

On (b)(6) my husband and i had our old folks' covid booster shots.We took our shots at walmart.I did not want to use walmart but we had much difficulty finding a place where the old folks' booster was provided.The lady stuck a round patch on my arm then needled the shot through the patch.Seemed the patch was rubber or latex.All the other vaccinations i received were just a simple prick after an alcohol wipe, no patch, almost no pain, but this shot hurt.I was surprised that it hurt.It hurt more than a shot should hurt when i was pricked.I had asked why the round rubber patch.I thought it odd that a needle would go through a rubber patch then into my arm.Now - over a month later, my arm at the location of the shot has developed a lingering soreness.It is too much soreness to ignore and seems to be increasing rather than decreasing.That is not right.I had little reaction to the prior three shots for covid.I think that a tiny dab of the plastic or latex of the patch was shoved into my arm.I think that is why my arm is sore where the needle went in.From the internet: the bandage is circular, with an adhesive membrane.A nurse cleans the patient's arm, applies the barrier bandage, and then administers the shot right through the bandage.It then acts immediately as a band-aid to catch and conceal any fluids from the broken skin.The barrier bandage is constructed of a self-sealing, non-coring, elastomeric membrane.Which is another way of saying once the needle passes through the barrier, it reseals preventing any fluid from coming out, (b)(6) said.(b)(6) is the ceo of "inject-safe?" barrier bandages. overall (b)(6) said the product is a safer, quicker, and more affordable way to administer a vaccine.I very strongly disagree and believe that although most will not have plastic stuck into their arm.This is not good and not right and my arm still hurts 05/27/2022.Fda safety report id # (b)(4).

• Brand Name: BARRIER BANDAGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): INJECTION SAFETY INDUSTRIES LLC.
• MDR Report Key: 14574612
• MDR Text Key: 293280250
• Report Number: MW5110021
• Device Sequence Number: 1
• Product Code: KGX
• 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: 05/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Patient Sequence Number: 1
• Treatment: OMEGA XL
• Patient Outcome(s): Disability
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White