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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO(TM) SPORT HINGED KNEE BRACE LIMB ORTHOSIS

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3M HEALTH CARE FUTURO(TM) SPORT HINGED KNEE BRACE LIMB ORTHOSIS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/04/2017
Event Type  Injury  
Manufacturer Narrative

Device was not returned by customer; no lot number was provided. Evaluation was not possible. Device manufacture date could not be determined. The product packaging contains the following statement: "caution: some individuals may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician". The customer appeared to follow the instructions for use. The customer noted that she wore the brace over leggings; direct skin contact would have been limited to the hands. The customer did not provide photos of the rash on any location other than the face. On the date the customer purchased the knee brace, she also purchased cosmetics. It is unknown if the leggings or the cosmetics were involved in the rash. Individual patent physiology is the most likely cause of the skin issues.

 
Event Description

A female customer wore a futuro¿ sport hinged knee brace on her right leg over leggings during a work-out. She alleged intense itching, burning, and swelling after a few hours. She removed the brace. She alleged that when she scratched the area, welts/hives appeared and began to spread. The woman alleged that by the next morning the rash had spread over her body to her face. She alleged a feeling that her throat was closing. She went to the hospital and was given 3 prescriptions including one for prednisone. After one week the skin issue had mostly resolved.

 
Manufacturer Narrative

Patient's md office reported on (b)(6) 2018, that patient received treatment for a reaction that spread from right knee to the back and face. Patient was reported to have a history of a latex and neoprene allergy. The purpose of this follow-up report was to provide this new information.

 
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Brand NameFUTURO(TM) SPORT HINGED KNEE BRACE
Type of DeviceLIMB ORTHOSIS
Manufacturer (Section D)
3M HEALTH CARE
2510 conway avenue
st. paul MN 55144
Manufacturer (Section G)
WINNING INDUSTRIAL CO., LTD
sha jing keng industrial zone
fushan district
liaobu, dongguan guangdong 52340 1
CH  523401
Manufacturer Contact
bryan becker
2510 conway avenue
st. paul , MN 55144
6517375578
MDR Report Key6984368
Report Number2110898-2017-00140
Device Sequence Number1
Product CodeIQI
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberN/A
Device Catalogue Number48579EN
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/27/2017 Patient Sequence Number: 1
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