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

Model Number N/A

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

Patient Problems Local Reaction (2035); Skin Irritation (2076)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

Model, serial, and lot # information was not provided by customer.The device has not been returned by the customer.Product analysis is pending receipt of device from customer.The customer was diagnosed with having a neoprene allergy.The reported symptoms resolved within 3 weeks after prescribed treatment.The product's primary packaging legal disclaimer states: caution: some individuals may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician.

Event Description

A (b)(6) female customer purchased the referenced wrist brace per the recommendation of her staff workers.The wrist support was worn intermittently on (b)(6) 2018, and all day the following day.On (b)(6) 2018, the woman removed the wrist support in the afternoon.The woman alleged the support was removed due to noticing a bad skin reaction.On (b)(6) 2018, the woman reported her wrist was swollen and "looked almost burnt".The woman visited a gp that same day.The doctor diagnosed the woman with having a neoprene allergy.The gp prescribed the woman an unspecified, strong steroid cream and an unspecified antihistamine.The woman was instructed to use the prescribed medications for one week.The woman reported her symptoms resolved within 3 weeks.

• Brand Name: FUTURO¿ SPORT ADJUSTABLE WRIST SUPPORT
• Type of Device: LIMB ORTHOSIS
• 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, mexico 32605 ; MX 32605
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 8084471
• MDR Text Key: 127611951
• Report Number: 2110898-2018-00104
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• 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: 09033EN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 33 YR