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 2017-10-27 for FUTURO(TM) SPORT HINGED KNEE BRACE N/A 48579EN manufactured by 3m Health Care.
[90475173]
Device was not returned by customer; no lot number was provided. Evaluation was not possible. Device manufacture date could not be determined. The product packaging contains the following statement: "caution: some individuals may be sensitive to neoprene or neoprene-blend rubber. If a rash develops, discontinue use and consult a physician". The customer appeared to follow the instructions for use. The customer noted that she wore the brace over leggings; direct skin contact would have been limited to the hands. The customer did not provide photos of the rash on any location other than the face. On the date the customer purchased the knee brace, she also purchased cosmetics. It is unknown if the leggings or the cosmetics were involved in the rash. Individual patent physiology is the most likely cause of the skin issues.
Patient Sequence No: 1, Text Type: N, H10
[90475174]
A female customer wore a futuro? Sport hinged knee brace on her right leg over leggings during a work-out. She alleged intense itching, burning, and swelling after a few hours. She removed the brace. She alleged that when she scratched the area, welts/hives appeared and began to spread. The woman alleged that by the next morning the rash had spread over her body to her face. She alleged a feeling that her throat was closing. She went to the hospital and was given 3 prescriptions including one for prednisone. After one week the skin issue had mostly resolved.
Patient Sequence No: 1, Text Type: D, B5
[100078460]
Patient's md office reported on (b)(6) 2018, that patient received treatment for a reaction that spread from right knee to the back and face. Patient was reported to have a history of a latex and neoprene allergy. The purpose of this follow-up report was to provide this new information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2017-00140 |
| MDR Report Key | 6984368 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-10-27 |
| Date of Report | 2018-01-24 |
| Date of Event | 2017-09-04 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2017-10-27 |
| 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 | WINNING INDUSTRIAL CO., LTD |
| Manufacturer Street | SHA JING KENG INDUSTRIAL ZONE FUSHAN DISTRICT |
| Manufacturer City | LIAOBU, DONGGUAN GUANGDONG 523401 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURO(TM) SPORT HINGED KNEE BRACE |
| Generic Name | LIMB ORTHOSIS |
| Product Code | IQI |
| Date Received | 2017-10-27 |
| Model Number | N/A |
| Catalog Number | 48579EN |
| Lot Number | N/A |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-27 |