MAUDE Adverse Event Report: 3M HEALTH CARE ACE BRAND KNEE 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 08/04/2019

Event Type  Injury  

Manufacturer Narrative

Patient information not provided.Exact date of event was not provided.1 year post incident report date was used as d.O.E.Product lot # was not provided.This product is exempt from udi.Initial reporter's occupation is unknown.Product lot # was not provided, therefore manufacture date is unknown.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 tbo.A review of the complaint history found no trends.3m will continue to monitor.End of report.

Event Description

A female consumer reported that she first wore an ace knee support on her left knee in 2019.Exact date and duration of wear was not specified.The consumer reported that she has an arthritic condition.The consumer alleged that she experienced an allergic reaction to the support.She described the reaction as a small patch of irritation which spread around her leg.The consumer reported the following food allergies: wheat, soy and dairy.The consumer reported that she experienced irritation from the rubber in girdles used in the past.She visited a doctor who prescribed triamcinolone acetonide lotion 1% and 5% cream to treat the area.The consumer wore the support again on (b)(6) 2020.The support was worn for most of the day.The consumer was reportedly sweating under the support and spent two hours in dance class during wear.After the support was removed, she alleged the skin area began to get red, bumpy and itchy.The bumps reportedly turned white.The consumer applied alcohol and poison ivy medication she had on hand on the area.She then used an old prescription of triamcinolone acetonide lotion and cream on the area.The skin area reportedly began to clear up.

• Brand Name: ACE BRAND KNEE SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul, mn
• Manufacturer (Section G): WINNING INDUSTRIAL CO., LTD.; hua nan industrial zone, no.3; jin-fu xi lu , liaobu; dongguan guangdong, china 52340 6; CH 523406
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, mn ; 7375578
• MDR Report Key: 10454584
• MDR Text Key: 204536735
• Report Number: 2110898-2020-00047
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 907004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention