MAUDE Adverse Event Report: 3M HEALTH CARE FUTUROTM SPORT MOISTURE CONTROL KNEE SUPPORT; KNEE ORTHOSIS

Model Number N/A

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

No information provided.No information provided by customer.Device not returned.Device was not returned by customer.No lot number was provided.Device manufacture date could not be determined.The product packaging contains the 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 continued to wear the knee support after the initial appearance of skin redness and itch.

Event Description

A male customer wore a futurotm sport moisture control knee support on his right leg for 4-5 hours while using crutches.He removed the support and alleged the skin under the support was red and itchy.The man applied over-the-counter topical diphenhydramine.The next day the man wore the support for 5-6 hours.He alleged the skin under the support became red, hot, itchy, and swollen.He alleged blisters, pustules, and bumps on his right leg, on his left leg that had touched the knee support, on the inside of his left arm, and on the back of his neck.The man applied diphenhydramine and went to his doctor.He was diagnosed with an allergic reaction.The doctor prescribed methylprednisolone, amoxicillin/clavulanic acid, and valacyclovir.The reaction subsided.

• Brand Name: FUTUROTM SPORT MOISTURE CONTROL KNEE SUPPORT
• Type of Device: KNEE ORTHOSIS
• 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: 6778514
• MDR Text Key: 82460222
• Report Number: 2110898-2017-00097
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• 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: 45697EN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• 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 Number: 1
• Patient Outcome(s): Other