MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO¿ SPORT WRIST SUPPORT; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problems Skin Irritation (2076); Swelling (2091)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

Weight: no information was provided.Lot #: product lot # not provided.Manufacture date: no lot # was provided, therefore device manufacture date is unknown.Health professional: initial reporter's occupation was not provided.The device was not returned for evaluation.Product lot # was not provided.Primary packaging indicates that if discomfort or pain results, persists or increases, discontinue use and consult a physician.Packaging also indicates how to wear.Complaint history was reviewed over the past 24 months for the products global sales code (gsc) of (b)(4) and the reported failure.No trends were observed.A follow up report will be submitted if device is received and analyzed.

Event Description

A (b)(6) caucasian female consumer reported she recently underwent surgery for a broken wrist.She purchased and wore the referenced wrist support.Exact duration of wear was unknown.The consumer alleged her arm developed a rash and doubled in size.The reaction was reported to have occurred within approximately 2-3 days of wear.The consumer reported the rash area was very red and raised with bumps.She reported experiencing no pain from the affected area.The consumer reported an allergy to latex.The consumer reported she consulted her husband who is a (b)(6).The consumer's husband advised her to use triamcinolone acetonide ointment 1% on the affected area.The steroid cream was applied for a couple of days to treat symptoms.On (b)(6) 2019, the consumer reported the swelling gradually subsided and went down within a week.A cotton sleeve was worn over the rash area.The skin redness was reported to take longer to resolve and completely diminished within a couple of weeks.The consumer reported her physical therapist recommended she discontinue use of the wrist support and fitted her for a splint.

Manufacturer Narrative

Product was received from the consumer on april 19, 2019.The returned product was analyzed.Updated method, results, and conclusion codes.The device was returned and evaluated.No primary packaging was returned, therefore, product lot # remains unknown.The product was inspected and looked new in appearance.There were no visual defects noted with exception of sewing thread which was not trimmed.Product was as expected.Some consumers may have sensitivities to neoprene.The primary packaging does contain a caution statement for neoprene as follows: caution: some individuals, may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician.

• Brand Name: FUTURO¿ SPORT WRIST SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): 3M EDUMEX, S.A. DE C.V.; 6620 oriente; calle ramon rivera lara; cd. juarez chihuahua, 32605 ; MX 32605
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 8535375
• MDR Text Key: 142621177
• Report Number: 2110898-2019-00055
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• 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: 09033EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2019
• 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
• Patient Age: 61 YR