MAUDE Adverse Event Report: ACE BRAND, SUBDIVISION OF 3M CONS ACE SELF-ADHERING ELASTIC BANDAGE

Model Number 207461

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Reaction (2414); Skin Tears (2516)

Event Date 07/26/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 i purchased from a (b)(6) grocery store pharmacy an ace brand self adhering elastic bandage.I wrapped my right knee with it to support it while mowing my yard and doing other various work outside and in my house.It seemed to give adequate support and certainly stayed in place due to its adhesive laced property.When i unwrapped the bandage from my knee that night; it wouldn't come off and as i thought it was just similar to coban medical wrap, i gave it a good jerk and pulled it off.When i did that, it was extremely painful and i noticed i was bleeding somewhat profusely.I am on an aspirin regimen from my doctor and under treatment for hypertension, and type 2 diabetes due to high blood sugar, i take 1/2 of an adult aspirin per day, or about 160-200 mg of aspirin daily, and have for some years, for that reason i think i sometimes have what some call "tissue paper skin" on my hands and other places; but i have never had it on my knees before.But in the process of removing that self-adhering ace bandage, i tore off almost every bit of the top layer of skin on the inside of my right knee and even some off the sides where the bandage came into direct contact with my skin.At the moment and since then i have had to wrap my knee with gauze bandages and antibiotic ointment to keep infection and contamination away from my knee, and it is very painful to walk or work at the moment.I am (b)(6) years of age and am a magnetic imaging technologist here in (b)(6).The name of the product is ace self-adhering elastic bandage, the stock number on the package is number 207461, it is a 3 inch width elastic ace bandage, manufactured by the ace company, a subdivision of the 3m consumer health care corporation.The number at the bottom of the barcode is (b)(4).I wrapped my knee exactly as the instructions were given, and there was absolutely no warnings given on the package pertaining to any reaction or interaction with any medicine, regimens or warning due to excessive adhesivity.I feel that this product was inadequately engineered and/or tested in different age groups or medical conditions and no warnings are on the packages to steer or warn of the possible interactions.At the very least warning should have been given to those on a long time aspirin regimen of the possible skin effects, and that the adhesive or adhesive properties contributed to my injury.I am requesting that you review my case and any other caes of this that you may have received and take the appropriate action to protect myself and other older consumers who are the most likely to use this product.

• Brand Name: ACE SELF-ADHERING ELASTIC BANDAGE
• Type of Device: ACE SELF-ADHERING ELASTIC BANDAGE
• Manufacturer (Section D): ACE BRAND, SUBDIVISION OF 3M CONS
• MDR Report Key: 3977503
• MDR Text Key: 20455584
• Report Number: MW5037555
• Device Sequence Number: 1
• Product Code: FQM
• 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: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 207461
• Device Lot Number: 51131
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 95