MAUDE Adverse Event Report: 3M HEALTH CARE ACE¿ 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); Skin Irritation (2076)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter's occupation is unknown.Product lot # was not provided therefore manufacturing date is unknown.The device was not returned for evaluation.The consumer discarded the product after use.Product lot # is unknown.Without this information, root cause cannot be determined.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 caucasian, female consumer applied the referenced product to her left knee on (b)(6) 2019.The elastic bandage was worn while snowshoeing and napping.The product was worn for approximately 12 hours and then removed.The consumer alleged she discovered her skin underneath the bandage had a red, raised rash the next day.She reported the rash was very itchy and painful to the touch.The consumer reported her right knee also had a rash present, though less severe.The consumer indicated the right knee rash may have been caused by her knees touching while napping.The consumer reported she had experienced reactions to adhesives in the past.No known allergies were specified.The consumer visited a pa and was prescribed betamethasone 1% along with oral cortisone tablets.The consumer also took benadryl for symptoms.The reported symptoms completely resolved within 7 days.

• Brand Name: ACE¿ 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: 8544931
• MDR Text Key: 142923372
• Report Number: 2110898-2019-00056
• 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: Other
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 69 YR