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)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

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 manufacture date requested.Waiting on this information.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 (b)(4).A review of the complaint history found no trends.

Event Description

A male consumer purchased the referenced knee support on (b)(6) 2020.The consumer first wore the support, while playing golf, on (b)(6) 2020 for approximately 4 hours.The consumer alleged he noticed his skin, where the product's straps came in contact, was slightly red after removal.He wore the support again, while playing golf, two days later for approximately 4-5 hours.The consumer alleged his skin appeared very red after removal.The reddened skin was reportedly located where the product's straps had been located around the leg, above and below his knee.He alleged the skin area looked like "poison ivy" and was very itchy, red and bumpy.No known allergies or skin sensitivities were specified.The consumer visited a doctor on (b)(6) 2020.The consumer reported that his doctor diagnosed the affected skin area as contact dermatitis and prescribed clobetasol steroid cream.On (b)(6) 2020, the consumer reported that the area was almost completely healed following the prescribed treatment.

• 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: 10161813
• MDR Text Key: 195372855
• Report Number: 2110898-2020-00031
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2020

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: 45697ENR
• Device Lot Number: 18352J
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/17/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention