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 Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 01/03/2022

Event Type  Injury  

Manufacturer Narrative

Age, weight, ethnicity: not reported.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 male customer (age unspecified) reported an incident regarding the ace¿ brand hinged knee brace.On the evening of (b)(6) 2022, he wore the support on his left knee.After wearing for 2 hours, he alleged his leg started to itch so he removed the support.After the support was removed, he allegedly noticed rash near his knee cap.On an unspecified date, he allegedly went to the doctor and he was prescribed a steroid shot for the alleged rash.Currently, there is scar or discoloration around his knee.He is worried because the alleged area looks like a sun burn when he showers and feels like someone is holding an ice park on the area when he leans on concrete.No allergies reported.

• 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 52340 6; CH 523406
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 13443255
• MDR Text Key: 285172070
• Report Number: 2110898-2022-00009
• 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
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• 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: 21079W9
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2021
• 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
• Patient Sex: Male
• Patient Race: White