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 Irritation (2076); Skin Inflammation/ Irritation (4545)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Patient weight: this information was not provided.Product lot # not provided.Initial reporter's email address was not provided.Initial reporter's occupation is unknown.Product lot # was not provided therefore manufacturing date is unknown.The device was not returned for evaluation.Product lot # is unknown.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 female customer, (age unspecified) alleged she had an allergic reaction to the referenced product.She reported she wore the product on her wrist and arm for a few days without issues.She then washed the product per the instruction on the product (rinsed in plain water without soap and allowed to dry) and then wore it again.She alleged that on (b)(6) 2021, she broke out in hives like poison ivy.She alleged the reaction got worst and was all over her arm, wrist and hand.She alleged the reaction looked like a red copy of the bandage.She stopped wearing the product the same day she noticed the alleged injury.She went to the urgent care twice (date not reported).The first time she went to the urgent care, she was prescribed a 6 days dose of steroid and antihistamine (name of medications was not specified).The second time, she was prescribed 12 days dose of a strong steroid (prednisone).She stated the prescribed medication helped resolved the alleged injury.No allergies or medical history reported.

• 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: 11387961
• MDR Text Key: 233973922
• Report Number: 2110898-2021-00012
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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
• Date Manufacturer Received: 02/01/2021
• 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