FUTURO ULTRA SHEER KNEE HIGHS FOR WOMEN
Received May 20, 2021 · Event occurred Feb 19, 2021
Report 2110898-2021-00034 · MDR key 11860233
Device
Generic name
Medical Support Stocking
Manufacturer
3m Health CareModel number
N/ACatalog number
71060EN
Lot number
20268E
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Rash
- Skin Inflammation/ Irritation
- Pain
- Rash
- Skin Inflammation/ Irritation
Narrative
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.
Description of Event or Problem
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.