MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO¿ SPORT HINGED KNEE BRACE; 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); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

Age or dob, weight, ethnicity: not reported.Expiration date: this product has no shelf life, therefore no expiration date.This product is exempt from udi.Product lot # was not provided, therefore manufacture date is unknown.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 eab.Review of complaint history found no trends.End of report.

Event Description

A male customer (age unspecified) reported an incident regarding the futuro hinged knee brace.He purchased the product about 2 to 3 months ago.About one month ago, he wore the brace for the first time on his left knee.The brace was in place for a day.He allegedly felt uncomfortable during the day and by the end of the day, after he removed the brace, the area allegedly looked like poison oak.The area was allegedly itchy, scabby and with red bumps.He used an unspecified antibacterial soap to shower and applied an unspecified ointment on the alleged injury.The alleged injury resolved after a few days.On (b)(6) 2021, the second time he wore the brace, he wore for about 5 hours.He allegedly experienced the same issue (area was allegedly itchy, scabby and with red bumps).He showered immediately he noticed the alleged injury and again at 2 in the morning.On an unspecified date, he allegedly noticed puss was draining from the area where the brace touched his skin, his knee was warm, and the area looked infected.He washed the area with an unspecified antibacterial soap.On an unspecified date, he was seen by different doctors and was referred to the emergency room (er).The doctors in the er, diagnosed the bumps on his neck and back as staph infection.He was prescribed an unspecified antibiotics and steroids.He alleged the medications caused insomnia.He was allegedly awake for more than 48 hours.On an unspecified date, we went to see his primary care doctor.His doctor informed him that the alleged injury is not a staph infection but a reaction to the knee brace.He stopped using the antibiotics and steroids that was prescribed in the er and he is currently applying an unspecified tropical medication on his left knee.He is allergic to cat hair and aspirin.No medical history or intervention reported.

• Brand Name: FUTURO¿ SPORT HINGED KNEE BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• MDR Report Key: 12636387
• MDR Text Key: 277624176
• Report Number: 2110898-2021-00063
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 48579EN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• 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): Required Intervention