MAUDE Adverse Event Report: 3M HEALTH CARE ACE¿ BRAND SELF-ADHERING ELASTIC BANDAGE; BANDAGE, ELASTIC

Model Number N/A

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

Pt information: this information was not provided.Product lot # was not provided for product purchased in 2018.Product lot # was not provided for product purchased in 2018 therefore manufacturing date is unknown.The device was not returned for evaluation.Product lot # is unknown for the product that was purchased in 2018.Product packaging indicates: if any skin irritation occurs, discontinue use and consult a physician.Complaint history was reviewed over the past 24 months for the product's global sales code of tba and the reported failure.No trends were observed.3m will continue to monitor.

Event Description

A (b)(6)-year-old female customer reported an incident regarding the ace self adhering bandages.She purchased the one of the bandages in 2018 and the other bandage in 2021.On (b)(6) 2021, she used the bandage she purchased in 2018 for the first time.She applied the bandage on her left ankle/foot for sprained ankle.She wore for 24 hours on (b)(6).On (b)(6) 2021, she wore the bandage during the day.The last few days of using the bandages, for about 3 to 4 day, she combined the bandage she purchased in 2018 with bandage she purchased in 2021.On (b)(6) 2021, the area was allegedly noted with raised red rash bumps (maculopapular rash), itching, papules and dermatitis in the same shape as the bandage.On (b)(6) 2021, she stopped using the ace self adhering bandages and used an unspecified cloth bandage.She used the cloth bandage only for one day.On (b)(6), she applied a prescription topical cortisone that was prescribed for sun related skin issue on the alleged injury.On (b)(6) 2021, the dermatologist prescribed oral prednisone, cortisone cream and betamethasone dipropionate cream 0.05%.She also used some benadryl and antihistamine.On (b)(6) 2021, she went to her primary care physician and she was given a shot of depo-medrol and additional oral prednisone.Her physician diagnosed the alleged injury as allergic contact dermatitis.The alleged injury is getting better but get irritated if anything touches the area.The area affected is the top of her foot, entire ankle and the calf area (3 inches above the ankle bone).If she itches the area, the itching/rash spreads all over left and right leg.She alleged the injury was a level 10 severity when it occurred but currently a level 2 severity.She allegedly still has some redness and bumps around her ankle.She is allergic to tetracycline and was previously treated for a rash that was caused by sun exposure.

• Brand Name: ACE¿ BRAND SELF-ADHERING ELASTIC BANDAGE
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): 3M EDUMEX, S.A. DE C.V.; 6620 oriente; calle ramon rivera lara; cd. juarez, chihuahua 32605 ; MX 32605
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 12956610
• MDR Text Key: 282209376
• Report Number: 2110898-2021-00074
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 207460
• Device Lot Number: 21237J
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female