MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO(TM) SPORT MOISTURE CONTROL KNEE SUPPORT; KNEE BRACE

Model Number N/A

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 01/28/2017

Event Type  Injury  

Manufacturer Narrative

The consumer stated that she did not seek medical attention for 4-5 weeks after skin irritation noted.The product packaging contains the caution statement: caution: some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician." customer misuse is probable.The customer did not specify the size of the leg on which she wore the support, or the tension applied.It is not known if the support was properly fit or adjusted.

Event Description

A female customer wore a futuro¿ sport adjustable knee stabilizer for 2 hours on (b)(6) 2017 while sight-seeing.The woman alleged an itchy, burning raised rash where the support touched her skin.She applied unspecified over-the-counter topical products.The woman did not seek medical attention because she hoped the alleged rash would continue to heal on its own.By (b)(6) the area had improved although the woman alleged raised bumps and some itch remained.The woman went to a doctor in early (b)(6) where she was given unspecified oral and injectable steroids.The itching resolved and the area was healing within one week.

Manufacturer Narrative

In summary the following changes were made from the initial report and which are part of this follow-up report: original report indicated product name as "futuro(tm) sport adjustable knee stabilizer".When product was returned it was "futuro(tm) sport moisture control knee support", manufacturer name, city and state address were changed per this report; previously stated address was incorrect.Changed catalog number to 45697en.Return date was changed to 3/9/2017.Added manufacturing site address which was incorrectly listed under in initial report.Returned product was visually inspected and showed no evidence of visual defects.End of report.

• Brand Name: FUTURO(TM) SPORT MOISTURE CONTROL KNEE SUPPORT
• Type of Device: KNEE BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; calle ramon rivera lara; 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: 6411666
• MDR Text Key: 70170760
• Report Number: 2110898-2017-00031
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

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 Number: N/A
• Device Catalogue Number: 45697EN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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