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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY ACE¿ DELUXE WRIST BRACE; ORTHOSIS, LIMB BRACE

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3M COMPANY ACE¿ DELUXE WRIST BRACE; ORTHOSIS, LIMB BRACE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076)
Event Date 09/29/2019
Event Type  Injury  
Manufacturer Narrative
Weight: information was not provided.The returned product was evaluated.The product showed little signs of wear.The size selection, as measured around the wrist at the smallest point, is 5 1/2 to 9 inches.It is unknown if the consumer's wrist matched the size selection.If the brace were too small, it could potentially cause friction/rubbing.No visible signs of abnormalities with the returned brace.Incorrect size or towel placed under brace may have added to possible rubbing if too tight.Root cause could not be confirmed.Packaging indicates that if discomfort or pain results, persists or increases, discontinue use and consult a physician.Complaint history was reviewed for the past 2 years for the product's global sales code (gsc) of tbc and the reported failure code.No trends were observed.3m will continue to monitor.
 
Event Description
A (b)(6) year old white male consumer reported he recently had a fiberglass cast removed for a fractured left wrist.The consumer was provided an alternative brand wrist support to use.The man alleged he experienced a skin reaction after wearing the support for 1-2 days, (b)(6) 2019.The reaction was described as slightly red, itchy skin with little vestibules bumps on the bottom of the wrist, side and top of hand.The consumer reported an allergy to neoprene.No other known allergies/skin sensitivities were specified.The consumer purchased the referenced wrist brace on (b)(6) 2019.The brace was worn for two days, (b)(6) 2019.The consumer wore a towel between the brace and his skin.The brace was reportedly not worn at night.The man reported the bottom of his wrist, side and top of hand were still itchy with little vestibules bumps.The consumer alleged he awoke in the night due to an extreme itching sensation on the top of his hand.The brace was reportedly not being worn at that time.A towel, secured by tape, was placed over the skin area and topical benadryl was applied.The consumer consulted a doctor.The doctor reportedly advised the consumer he experienced an allergic reaction to the brace.The doctor prescribed a triamcinolone 1% steroid cream and prednisone.The consumer followed the prescribed treatment.The affected area improved.An alternative brand wrist support was purchased.
 
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Brand Name
ACE¿ DELUXE WRIST BRACE
Type of Device
ORTHOSIS, LIMB BRACE
Manufacturer (Section D)
3M COMPANY
2510 conway avenue
st. paul,
Manufacturer (Section G)
DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD
lingxia village
liaobu town
dongguan guangdong,
CH  
Manufacturer Contact
bryan becker
2510 conway avenue
st. paul, MN 55144
6517375578
MDR Report Key9226419
MDR Text Key163785593
Report Number2110898-2019-00122
Device Sequence Number1
Product Code IQI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 10/23/2019
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 Number205276
Device Lot Number8103E2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Initial Date Manufacturer Received 10/01/2019
Initial Date FDA Received10/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age65 YR
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