MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO KNEE PERFORMANCE SUPPORT; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Swelling (2091)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity & race: information not provided.This product has no shelf life, therefore no expiration date.This product is exempt from udi.Initial reporter's occupation is unknown.Product lot # was not confirmed, therefore manufacture date is unknown.The device has not been received for evaluation.3m was unable to determine root cause.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales code of eab.A review of the complaint history found no trends.

Event Description

A (b)(6) male customer purchased the referenced knee support on (b)(6) 2020.The customer first wore the support on (b)(6) 2020 for approximately 4-5 hours.The outside temperature was reportedly warm during wear.The customer alleged that he felt irritation on his knee during wear.He described the irritation as "like a heat rash".He alleged his skin was red, bumpy and itchy after the support was removed.The customer wore the support again on (b)(6) 2020, while performing yard work.The support was worn under jeans, for approximately 5-7 hours.He alleged that his skin was red, bumpy and itchy after the support was removed.The customer's leg allegedly swelled in areas, 4.5" below the knee and 4.5" above the back of the knee.Blisters reportedly developed on the customer's back leg and began to fill with fluid.No pre-existing conditions, known allergies or skin sensitivities were specified.The customer washed the skin area and applied caladryl and calamine lotion to help relieve the itching.He then wrapped his leg before going to bed.The customer visited a doctor on (b)(6) 2020.He reported that his knee was beet red bumpy, blistery, swollen and itchy at the time of doctor's visit.The customer's right ankle reportedly was also swollen.The doctor reportedly advised the customer that he had experienced an allergic reaction to "something".The doctor reportedly advised the customer that the ankle swelling may have been caused by other inflammation in his leg.The doctor prescribed prednisone for the swelling and lasix furosemide for water retention.The customer was also instructed to purchased otc hydrocortisone cream.On (b)(6) 2020, the customer reported that the skin area had improved following the prescribed treatment.The skin area reportedly still itched.The customer reported that he would continue with the prescribed treatment until complete.

• Brand Name: FUTURO KNEE PERFORMANCE SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul, mn
• 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 ; 7375578
• MDR Report Key: 10408244
• MDR Text Key: 203627116
• Report Number: 2110898-2020-00044
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 45696ENR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR