MAUDE Adverse Event Report: 3M HEALTH CARE ACE¿ KNEE SUPPORT; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

Product lot # not provided.No lot # was provided, therefore device manufacture date is unknown.Initial reporter's occupation is unknown.The device was not returned for evaluation.Product lot # was not provided.Without a sample, photo, or lot number there is insufficient information to determine root cause.Primary packaging indicates the following: caution: some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician.Complaints were reviewed over the past 24 months for (b)(4) and reported failure.No trends were observed.End of report.

Event Description

A (b)(6) female consumer reported she recently underwent left knee meniscus surgery.She wore the referenced knee support overnight on (b)(6) 2019.The knee support was worn for approximately 6 hours.The following morning, the consumer alleged a rash developed on her left leg from the mid-thigh to mid-calf.The rash was described as red dots/spots with some raised areas.The consumer alleged rash spots also appeared on her right leg.The consumer reported the affected areas itched.No known allergies or skin sensitivities were specified.The consumer visited a dermatologist on (b)(6) 2019.The affected area was diagnosed as contact dermatitis.The doctor prescribed clobetasol propionate ointment.Post visit, the consumer reported the affected area appeared to become redder and rash spots started to appear on the back of her arms.The consumer visited the er on (b)(6) 2019 due to rash concerns.She reported the er confirmed the contact dermatitis diagnosis.No additional medication was provided.The consumer visited her primary care md on (b)(6) 2019, to assess the affected area.The consumer reported the rash started to heal and fade by the time follow up appointment was conducted with her dermatologist on (b)(6) 2019.

Manufacturer Narrative

Product brand name corrected.The product related to this report is an ace¿ knee support, catalog # 207247.

• Brand Name: ACE¿ KNEE SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• 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: 8616000
• MDR Text Key: 145256817
• Report Number: 2110898-2019-00075
• 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,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• 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: 207247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2019
• 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
• Patient Age: 76 YR