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U.S. Department of Health and Human Services

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

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3M HEALTH CARE ACE¿ SELF-ADHERING ELASTIC BANDAGE; BANDAGE, ELASTIC Back to Search Results
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.
 
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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 Key8544931
MDR Text Key142923372
Report Number2110898-2019-00056
Device Sequence Number1
Product Code FQM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberN/A
Device Catalogue Number207460
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/01/2019
Initial Date FDA Received04/24/2019
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 Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age69 YR
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