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

Model Number N/A

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

Patient Problem Laceration(s) (1946)

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

A2, a4 - a5: information not provided.D4: lot number was not provided.D4: lot number was not provided; therefore, expiration date cannot be determined.H4: lot number was not provided, therefore manufacture date cannot be determined.H10: no sample has been received for analysis.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales code of tbd.Review of the complaint history found no trends for harms code alleged medical injury.End of report.

Event Description

A male customer (age unspecified) reported an incident regarding the ace hinged knee brace.On (b)(6) 2023, while the brace was in place, he was jogging and fell, and the metal stabilizer allegedly detached from the brace and sliced opened his kneecap.The alleged injury was approximately 1" deep by 1" wide.He alleged the injury caused limited flexibility in his right leg.On an unspecified date, he went to the urgent care.At the urgent care the doctor prescribed an unspecified antibiotics to prevent infection and xray and mri was recommended.He plans to complete the mri and xray later.No allergies, medical history or intervention reported.

• Brand Name: ACE¿ BRAND KNEE SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN
• 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 ; 2510 conway avenue; 6517375578
• MDR Report Key: 17275405
• MDR Text Key: 318545484
• Report Number: 2110898-2023-00066
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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: 907017
• Date Manufacturer Received: 06/06/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male