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

Model Number N/A

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Fluid Discharge (2686)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

Device manufacture date is identified by an alpha code on the device.Device has not been returned.The consumer's doctor stated that the skin reaction may be related to neoprene in the product.The product is labeled as containing neoprene blend.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." end of report.

Event Description

A male customer wore an ace¿ moisture control knee support for approximately 8 hours a day for two days.On (b)(6) 2017 the man alleged that the area where the brace touched his skin was red and itchy with welts that oozed.The man went to his doctor and was given unspecified antibiotics, "cortisone" (delivery route not specified), and a "high power cream".The man alleged his doctor said that the skin issue could be related to neoprene.By the next day the skin irritation was improving.

• Brand Name: ACE(TM) MOISTURE CONTROL KNEE SUPPORT
• Type of Device: KNEE BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): WINNING INDUSTRIAL COMPANY, 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 Key: 6487142
• MDR Text Key: 72653140
• Report Number: 2110898-2017-00048
• 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: 03/15/2017

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: 209602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/12/2017
• 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