MAUDE Adverse Event Report: 3M HEALTH CARE ACE(TM) KNEE SUPPORT ONE SIZE ADJUSTABLE; ACE(TM) KNEE SUPPORT ONE SIZE ADJUSTABLE COMPRESSION

Model Number N/A

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

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

There is not enough traceability in the complaint to be sure of manufacturing location.Additional manufactures location: (b)(4).No lot # was provided, therefore device manufacture date is unknown.The device was not returned for evaluation.Product lot # was not provided.Without a sample, or lot number, there is insufficient information to determine root cause.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 (b)(6)-year old male customer alleged the ace adjustable knee adjustable compression support caused an allergic reaction above, below and on the back side of his knee.The customer stated that he wore the brace for 8 hours on (b)(6) 2020, without issues.The next day, he wore the brace for 6 hours.He alleged the area started to itch.The brace was removed.Customer alleged the skin area was red, inflamed, and had some blisters after removal.Customer alleged the blisters varied in size, some small, and some large.The customer visited a clinic on (b)(6) 2020.Customer reported the clinic prescribed him an unspecified antibiotic to treat the sores, antihistamine for the itching and he was advised to also get calamine lotion.Customer visited his dermatologist on (b)(6) 2020.The dermatologist reportedly provided him an unspecified ointment to apply twice daily.Customer reported he's still applying the ointment.Customer alleged red blotches were visible where the brace was worn but it's slowly going away.Customer reported the following allergies: fish and penicillin.Customer reported history of eczema, but stated it has slowly gone away since he was a child.

• Brand Name: ACE(TM) KNEE SUPPORT ONE SIZE ADJUSTABLE
• Type of Device: ACE(TM) KNEE SUPPORT ONE SIZE ADJUSTABLE COMPRESSION
• 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, china 52340 6; CH 523406
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 10842463
• MDR Text Key: 216317504
• Report Number: 2110898-2020-00055
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 207247
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/16/2020
• 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): Other; Required Intervention
• Patient Age: 56 YR