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

Model Number N/A

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

Patient Problems Pain (1994); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 02/19/2021

Event Type  Injury  

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 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
• Type of Device: MEDICAL SUPPORT STOCKING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): ELASTIC THERAPHY, LLC; 718 industrial park ave; asheboro NC 27205
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 11860233
• MDR Text Key: 251896322
• Report Number: 2110898-2021-00034
• Device Sequence Number: 1
• Product Code: DWL
• UDI-Device Identifier: 00051131215900
• UDI-Public: 051131215900
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• 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: 71060EN
• Device Lot Number: 20268E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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