MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO(TM) NIGHT WRIST SLEEP SUPPORT ADJUSTABLE; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problem Cyst(s) (1800)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

Device returned for evaluation 6/19/2018.The device was returned and evaluated on march 12, 2019.The sample was returned with no primary carton, so the lot number remains unknown.The product label states ace, kf and adj for adjustable.Kf implies the product was manufactured in 2017.Without a product lot #, exact manufacture date is unknown.The brace was examined for any visual defects.Pilling was observed, however no other issues were noted.No stitching issues were noted.Per the note attached with the returned support, the consumer's provider stated ".Has a retinacular cyst that was caused or aggravated by the use of her splint." consumer was sent copy of "trigger finger" faq sheet.This remains as isolated occurrence as reported for this support for the period of march 2017 - feb 2019.

• Brand Name: FUTURO(TM) NIGHT WRIST SLEEP SUPPORT ADJUSTABLE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD; lingxia village; liaobu town; dongguan guangdong, china 52340 5; CH 523405
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 7633571
• MDR Text Key: 112161555
• Report Number: 2110898-2018-00062
• Device Sequence Number: 1
• Product Code: IQI
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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: 48462EN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention