MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO¿ SPORT HINGED KNEE BRACE

Model Number N/A

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

Patient Problem Rash (2033)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Device manufacture date is identified by an alpha code on the device.Device has not been returned.Some individuals may be sensitive to the neoprene or neoprene-blend materials.The consumer reported that her husband wore the brace and had an alleged reaction with first use.Consumer continued to wear the brace on another occasion after the first alleged reaction.The package contains the following statements: "caution: some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician." another factor may be improper fit or adjustment of brace by the consumer.End of report.

Event Description

A woman reported that her husband wore a futuro¿ sport hinged knee brace for one day on approximately (b)(6) 2017.The man alleged a raised rash on his knee the next day.He stopped wearing the brace.No medical treatment was specified.The man wore the brace over long underwear for two hours on (b)(6) 2017.He alleged red swollen bumps and later, open sores, under the brace.The man went to his doctor on (b)(6) and was given an unspecified prescription steroid cream.The area improved.

• Brand Name: FUTURO¿ SPORT HINGED KNEE BRACE
• Type of Device: KNEE BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): SHA JING KENG INDUSTRIAL ZONE; fushan district; liao bu, dong guan 52340 1; CH 523401
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 6498831
• MDR Text Key: 72984609
• Report Number: 2110898-2017-00049
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• 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: 48579EN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• 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