MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-02-01 for FUTURO? SPORT MOISTURE CONTROL KNEE SUPPORT N/A 45696EN manufactured by 3m Health Care.
[134780991]
Product lot # not provided. No lot # was provided, therefore device manufacture date is unknown. The device was not returned for evaluation. Product lot # was not provided. Product packaging contains the following caution: some individuals may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician. Product complaint history was reviewed for the past 24 months and the reported failure. No trends were observed for this combination.
Patient Sequence No: 1, Text Type: N, H10
[134780992]
A nurse reported a male patient experienced a skin reaction after the referenced knee supports were worn. A male customer purchased two, size medium, knee supports on (b)(6) 2018. Both supports were worn on the same day of purchase for approximately 10 hours. Upon removal, the man alleged experiencing an intense itching, burning sensation, along with a red rash. The reaction was located where the knee supports touched skin. The supports were worn again later that day. The man applied gold bond itch cream and took oral benadryl for symptoms. He reported his only known allergy was to penicillin. The nurse reported the man's rash was in the shape of the knee supports. The rash was described as angry, fiery red, itchy, and burning. The nurse reported the rash appeared to not be as severe in the location of the open kneecap on the supports. The nurse reported the patient was "fine" and diagnosed with severe contact dermatitis. The doctor prescribed triamcinolone acetonide (1% topical cream) and benadryl, to use as needed. On (b)(6) 2019, the man reported the rash had not spread and appeared to be improving. The man reported he refilled the triamcinolone acetonide (1% topical cream). The man reported he had a skin specialist appointment the following day to evaluate the area. No further details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00022 |
| MDR Report Key | 8297778 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-02-01 |
| Date of Report | 2019-04-15 |
| Date of Event | 2018-12-31 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-05-07 |
| Date Added to Maude | 2019-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BECKER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517375578 |
| Manufacturer G1 | 3M EDUMEX, S.A. DE C.V. |
| Manufacturer Street | 6620 ORIENTE CALLE RAMON RIVERA LARA |
| Manufacturer City | CD. JUAREZ CHIHUAHUA, 32605 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURO? SPORT MOISTURE CONTROL KNEE SUPPORT |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-02-04 |
| Model Number | N/A |
| Catalog Number | 45696EN |
| Lot Number | 18127J |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-02-01 |