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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Irritation (2076)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BANDAGE, ELASTIC
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• MDR Report Key: 8544931
• Report Number: 2110898-2019-00056
• Device Sequence Number: 16755056
• Product Code: FQM
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 207460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR