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

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

Patient information not provided.Product lot # not provided.This product is exempt from udi.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 or lot number there is insufficient information to determine root cause.A product photo was provided.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales code of eab.A review of the complaint history found no trends.

Event Description

A female consumer (age not specified) reported wore the reference knee support (size l/xl) on her left knee, (b)(6) 2020.The support was worn while working for approximately 12 hours.The consumer alleged that she noticed red, raised bumps on her skin after the support was removed.No known allergies or skin sensitivities were specified.She alleged the skin area began to itch later that evening.The skin reaction was reportedly still visible and very itchy the next day.The consumer did not wear the product to work the next day.The consumer reported that she scratched the skin area under her work pants due to the itching sensation.The skin area reportedly began to ooze and weep clear liquid from the bumps.The liquid dripped reportedly down the consumer's leg.The consumer switched to wearing shorts to expose the skin area.The oozing bumps reportedly hardened.The consumer visited an urgent care.Urgent care staff diagnosed the affected skin area as contact dermatitis, infected with impetigo.The customer was prescribed oral antibiotic sulfa methoxazole, oral prednisone 20 mg and mupirocin 2% cream.The prescriptions were directed to be taken for 7-10 days.The customer reportedly took and applied the medications as prescribed.The customer reported that the skin area had almost fully cleared up after approximately two weeks.The skin area was reported to look somewhat gray, like "chicken pox scars".

• Brand Name: ACE OPEN PATELLA KNEE 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: 10106941
• MDR Text Key: 193624868
• Report Number: 2110898-2020-00027
• 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: 06/01/2020

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: 207733
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/01/2020
• 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