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); Contact Dermatitis (4546)

Event Date 06/12/2022

Event Type  Injury  

Event Description

A female customer (age unspecified) reported an incident regarding the ace¿ hinged knee brace¿.On sunday (b)(6) 2022, she started wearing the brace on an unspecified leg.The brace was in place for about 3 hours.She removed the brace before bed and did not notice any injury.On (b)(6) 2022, when she woke up, she allegedly noticed a huge rash on her leg.She alleged the rash was in the exact same shape as the brace.On an unspecified date, she allegedly noticed bumps and blister on the area.On an unspecified, she was prescribed steroids (prednisone) for the alleged rash by her doctor.Her doctor diagnosed the reaction as contact dermatitis.The alleged injury has not healed, the area looks like a burn.No allergies or intervention reported.

Manufacturer Narrative

Age or dob, weight, ethnicity, race: not reported.Lot#: not provided.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.

• 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: 14992872
• MDR Text Key: 295768283
• Report Number: 2110898-2022-00047
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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: 06/16/2022
• 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: White