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 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Patient information not reported.There is not enough traceability in the complaint to be sure of manufacturing location.Additional manufactures location: 3m edumex, s.A de c.V, 3m company, 3m consumer health care, 3m health care.(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.

Event Description

A female customer alleged she had an allergic reaction to the ace adjustable knee support with stabilizers.The night of monday (b)(6) 2021, she wore the brace to work.She wore it on her right knee.She had the brace on for 4 hours.While she had the brace on, the area was uncomfortable (tight).After she removed the brace, she alleged the area where the brace had touched her skin was very red and felt very hot.She treated the area by applying hydrocortisone cream to the area.On tuesday ((b)(6) 2021) morning some of the redness had subsided but she alleged the area was itchy and she could see the outline of where the brace was on her knee.She took a shower and cleaned the area, but the area was still very itchy.She continued to apply hydrocortisone cream to the area, and she took benadryl.She alleged that on (b)(6) 2021, she spoke to the doctor on phone and she was given a prescription strength hydrocortisone.She started using the prescribed cream and the alleged redness is resolved.No allergies or medical history reported.

• 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: 11582475
• MDR Text Key: 242783703
• Report Number: 2110898-2021-00021
• 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: 03/26/2021

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: 200290
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/29/2021
• 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