MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO¿ SPORT MOISTURE CONTROL KNEE SUPPORT; ORTHOSIS, LIMB BRACE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

Product lot # not provided.No lot # was provided, therefore device manufacture date is unknown.The device was not returned for evaluation.Product lot # was not provided.Product packaging contains the following caution: some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician.Product complaint history was reviewed for the past 24 months and the reported failure.No trends were observed for this combination.

Event Description

A nurse reported a male patient experienced a skin reaction after the referenced knee supports were worn.A male customer purchased two, size medium, knee supports on (b)(6) 2018.Both supports were worn on the same day of purchase for approximately 10 hours.Upon removal, the man alleged experiencing an intense itching, burning sensation, along with a red rash.The reaction was located where the knee supports touched skin.The supports were worn again later that day.The man applied gold bond itch cream and took oral benadryl for symptoms.He reported his only known allergy was to penicillin.The nurse reported the man's rash was in the shape of the knee supports.The rash was described as angry, fiery red, itchy, and burning.The nurse reported the rash appeared to not be as severe in the location of the open kneecap on the supports.The nurse reported the patient was "fine" and diagnosed with severe contact dermatitis.The doctor prescribed triamcinolone acetonide (1% topical cream) and benadryl, to use as needed.On (b)(6) 2019, the man reported the rash had not spread and appeared to be improving.The man reported he refilled the triamcinolone acetonide (1% topical cream).The man reported he had a skin specialist appointment the following day to evaluate the area.No further details were provided.

Manufacturer Narrative

The product was returned for evaluation and analyzed.Two knee supports were returned.Product lot #s 18127j & 18064j.Lot 18127j has a date of manufacture of: 5/7/2018.Lot 18064j had a date of manufacture of: 3/5/2018.These products do not have an established shelf life.The packaging confirmed the caution statement for neoprene, instructions for wear and use: "some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician." the supports were visually inspected, and both items appeared to be well worn.Several hanging threads; one seam with thread cluster noted on 18127j and lot 18064j had an open seam.As the consumer reported wearing both supports upon purchase, these are not suspected as out-of-the-box quality issues, but rather substantial wear.No other visual discrepancies were noted.Product complaint history was reviewed for the past 24 months and found no statistical trend.3m will continue to monitor.

• Brand Name: FUTURO¿ SPORT MOISTURE CONTROL KNEE SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• 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: 8297778
• MDR Text Key: 134780991
• Report Number: 2110898-2019-00022
• Device Sequence Number: 1
• Product Code: IQI
• 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,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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: 45696EN
• Device Lot Number: 18127J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• 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