MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO¿ SPORT WRIST SUPPORT

Model Number N/A

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

Patient Problems Itching Sensation (1943); Rash (2033); Blister (4537); Swelling/ Edema (4577)

Event Date 05/21/2022

Event Type  Injury  

Event Description

A female customer (age unspecified) reported an incident regarding the futuro¿ sport wrist support.She has nerve damage in both of her arms.On friday (b)(6) 2022, she wore the product on both wrists for support.The supports were in place for about 2 hours.She didn't wear the support to bed.When she woke up on saturday (b)(6) 2022, she allegedly noticed itchy blisters on both wrists.She alleged her legs and feet started to swell and she noticed fine bumps on her legs.On the same day, she went to the emergency room (er).At the er, she was informed she had an allergic reaction.She was prescribed hydrocortisone cream.The prescribed cream allegedly caused her to break out more and she was allegedly unable to sleep at night.She plans to go back to the er if the reaction worsens.On an unspecified date, the alleged itching resolved, and swelling was resolving.No allergies reported.

Manufacturer Narrative

Age or date of birth, weight: not reported.Device manufacture date: there is no expiry date claim since the brace is non-sterile.The device was not returned for evaluation.Without a sample there is insufficient information to determine root cause.Complaint history was reviewed for the past 24 months for the reported failure for product's global sales codes of eaa.Review of complaint history found no trends.

• Brand Name: FUTURO¿ SPORT WRIST SUPPORT
• Type of Device: FUTURO¿ SPORT WRIST SUPPORT
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): WINNING INDUSTRIAL CO., LTD.; dougguan south sun neoprene ru; shajingkeng industrial park; dongguan city,, china 52340 1; CH 523401
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 14763170
• MDR Text Key: 294763947
• Report Number: 2110898-2022-00040
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 09033ENR
• Device Lot Number: 21229W1
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American