MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-25 for FUTURO(TM) NIGHT WRIST SLEEP SUPPORT ADJUSTABLE N/A 48462EN manufactured by 3m Health Care.
[112161555]
Date of event reflects (b)(6) 2018, due to customer not providing exact date of alleged injury, but specifying injury occurred beginning of (b)(6) 2018. No information provided by customer. Device not returned. Device was not returned by customer by date of this report. No lot number was provided. Evaluation was not possible. Device manufacture date could not be determined. The product packaging offers information for fit size, how to wear, and how to wash. If pain/discomfort is noted the consumer should discontinue use. Possible causes for pain/discomfort/skin irritation may be related to the product being worn by user outside of intended size range ,the brace not being worn as intended, or a workmanship issue with stitching. Without the product being returned from the consumer for evaluation, root cause can't be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[112161556]
A female customer wore a 3m? Futuro? Night wrist sleep support for approximately two months, beginning around (b)(6) 2018. The woman alleged that she noticed a "growth" started to develop at the base of her thumb bone on her right hand. She alleged the growth was very painful. She discontinued wearing the wrist support in (b)(6) 2018, due to the growth. The woman scheduled an appointment with an orthopedic md for (b)(6) 2018. The woman reported she thought the growth may have been caused by the support rubbing against her skin. On (b)(6) 2018, the woman visited an orthopedic md. The md confirmed the growth/cyst was caused by the wrist support. Per doctor's instruction, she was advised to discontinue wearing the wrist support indefinitely. The doctor drew matter from the cyst. The woman will need to return to the doctor in 6 weeks if the growth/cyst has not gone away. The doctor advised surgery or cortisone will be needed at that time if the growth has not gone away. The doctor advised the injury was called "trigger finger". The woman reported the growth was still present as of (b)(6) 2018. She is massaging the growth and using heat on it daily to assist in the healing process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00062 |
| MDR Report Key | 7633571 |
| Report Source | CONSUMER |
| Date Received | 2018-06-25 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-25 |
| 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 | DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD |
| Manufacturer Street | LINGXIA VILLAGE LIAOBU TOWN |
| Manufacturer City | DONGGUAN GUANGDONG, CHINA 523405 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523405 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURO(TM) NIGHT WRIST SLEEP SUPPORT ADJUSTABLE |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2018-06-25 |
| Returned To Mfg | 2018-06-19 |
| Model Number | N/A |
| Catalog Number | 48462EN |
| Lot Number | N/A |
| 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 | 2018-06-25 |