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 Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 08/14/2022

Event Type  Injury  

Manufacturer Narrative

Age, weight, ethnicity - not reported.Lot# - not provided.Expiration date - the product does not have an expiration date.Lot# not provided.Therefore, unable to determine manufacture 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 hinged knee brace.She purchased the brace on (b)(6) 2022.On (b)(6) 2022, she wore the brace on her left knee.The brace was in place for an hour.After she removed the brace, she allegedly noticed the area was itchy.On (b)(6) 2022, the area was allegedly swollen and there were bumps that appeared like blisters.On an unspecified date, the blisters drained, and her skin was irritated.She finds it difficult to lay down because the alleged injury is all over her leg.On an unspecified date, she went to the doctor.The doctor prescribed triamcinolone - acetonide ointment and administered an unspecified injection for the alleged injury.She has a follow up appointment with the doctor on (b)(6) 2022, and a follow up with the orthopedic doctor on friday (b)(6) 2022.No allergies or medical history 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: 15531163
• MDR Text Key: 301103658
• Report Number: 2110898-2022-00098
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• 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
• Date Manufacturer Received: 09/06/2022
• 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): Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American