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

Model Number N/A

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

Patient Problems Abrasion (1689); Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Expiration date - the product does not have an expiration date.The device was not returned for evaluation.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales code of tbd.Review of complaint history found no trends.End of report.

Event Description

A female customer (age unspecified) reported an incident regarding the ace (tm) hinged knee brace.She purchased the brace about 6 weeks ago (exact date was not reported).One week after she purchased the brace, she wore it on her right knee (torn meniscus).She walked with the brace for about 30 to 40 minutes before she removed it.After the brace was removed, the area was allegedly red, itchy and with rash.She alleged the rash developed into blisters, and within a couple of days the blisters busted/drained (color of drainage was not reported).She allegedly felt burning sensation and itching after the blisters drained.She placed warm/cold towel on the alleged area to help with the itching.She went to the hospital a few days later (date was not reported).She was prescribed an unspecified antibiotic to prevent infection and benadryl for itching.She alleged the area is still itchy, with few scars and a light skin tone.She thinks the scar will be permanent.No allergies, medical history or intervention reported.

Event Description

On (b)(6) 2021, at 12:46 pm, she visited the emergency room (er).At the er rash and multiple superficial abrasions was noted on her right lower extremity.She also complained of 5 weeks onset of lumps bumps and callouses in an unspecified location.At the er, her temperature was 97.5 fahrenheit, blood pressure was 133/64 mm hg, pulse 93, respiration 16, oxygen saturation 98% on room air, weight 165 lb and body mass index (bmi) 28.5.She was prescribed bactrim ds (sulfamethoxazole-trimethoprim) 800- mg -160 mg tablet every 6 hours orally; benadryl (diphenhydramine) 25 mg tablet every 6 hours as needed for itching and prednisone 10 mg tablet daily.At 13:20 pm, she was discharged home in improved/stable condition.She was advised to follow-up with primary care physician or return to er if condition worsens.She allegedly suffered extreme pain and discomfort, anxiety, loss of sleep, endured months of painful treatment and therapy as a result of the alleged injury.Her past medical history includes hypertension.The customer's medication history included doxycycline monohydrate 100 mg daily by mouth and naproxen 500 mg 2 times daily by mouth as needed for pain.On (b)(6) 2021, the customer visited her doctor.She was diagnosed with right knee pain, left shoulder pain, lower back pain, hypertension, major depressive disorder - recurrent episode - mild degree and gerd (gastroesophageal reflux disease).The doctor wrote a prescription for right knee brace related to bilateral knee pain associated with meniscal tear and severe osteoarthritis.The doctor stated that the old brace was associated with rash and misfitting issues.No allergies reported.

Manufacturer Narrative

H10: the device was not returned for evaluation.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales code of tbd.Review of complaint history found no trends.End of report.

• Brand Name: ACE¿ BRAND HINGED KNEE BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• 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 55144 ; 6517375578
• MDR Report Key: 12258869
• MDR Text Key: 264489805
• Report Number: 2110898-2021-00044
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

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: 209600
• Device Lot Number: 20319W2
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2020
• 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): Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: Black Or African American