MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO ULTRA SHEER KNEE HIGHS FOR WOMEN; MEDICAL SUPPORT STOCKING

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth, weight, ethnicity, race: information not provided.The product does not have an expiration date.No sample has been returned to 3m for evaluation.Root cause of reported issue could not be established.Complaint history was reviewed over the past 24 months for the products global sales code (gsc) of eag and the reported failure.No trends were observed, end of report.
Event or Problem Description
A female customer (age unspecified) alleged the futuro¿ ultra sheer knee caused a raised, red, itchy rash all over her body (except for her face and back) after 2 weeks of use.She purchased the product in (b)(6) 2021.She wore the product from 6am to 10 pm daily for about 2 weeks.During the two weeks period she wore the product, she rinsed the product, but she did not wash with soap.She alleged she had difficulty sleeping because the itching was very bad.Her doctor prescribed medrol for itching (date unspecified).The alleged injury resolved 5 days after she started using the prescribed medication.She reported that 1.5 years ago she had a similar type of body rash after she underwent a hip replacement surgery (the doctor used adhesive sutures to close the incision).No allergies or medical history reported.

• Brand Name: FUTURO ULTRA SHEER KNEE HIGHS FOR WOMEN
• Common Device Name: MEDICAL SUPPORT STOCKING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11860233
• Report Number: 2110898-2021-00034
• Device Sequence Number: 16996815
• Product Code: DWL
• UDI-Device Identifier: 00051131215900
• UDI-Public: 051131215900
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 71060EN
• Device Lot Number: 20268E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other