MAUDE Adverse Event Report: 3M COMPANY ACE¿ DELUXE WRIST BRACE; ORTHOSIS, LIMB BRACE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

Weight: information was not provided.The returned product was evaluated.The product showed little signs of wear.The size selection, as measured around the wrist at the smallest point, is 5 1/2 to 9 inches.It is unknown if the consumer's wrist matched the size selection.If the brace were too small, it could potentially cause friction/rubbing.No visible signs of abnormalities with the returned brace.Incorrect size or towel placed under brace may have added to possible rubbing if too tight.Root cause could not be confirmed.Packaging indicates that if discomfort or pain results, persists or increases, discontinue use and consult a physician.Complaint history was reviewed for the past 2 years for the product's global sales code (gsc) of tbc and the reported failure code.No trends were observed.3m will continue to monitor.

Event Description

A (b)(6) year old white male consumer reported he recently had a fiberglass cast removed for a fractured left wrist.The consumer was provided an alternative brand wrist support to use.The man alleged he experienced a skin reaction after wearing the support for 1-2 days, (b)(6) 2019.The reaction was described as slightly red, itchy skin with little vestibules bumps on the bottom of the wrist, side and top of hand.The consumer reported an allergy to neoprene.No other known allergies/skin sensitivities were specified.The consumer purchased the referenced wrist brace on (b)(6) 2019.The brace was worn for two days, (b)(6) 2019.The consumer wore a towel between the brace and his skin.The brace was reportedly not worn at night.The man reported the bottom of his wrist, side and top of hand were still itchy with little vestibules bumps.The consumer alleged he awoke in the night due to an extreme itching sensation on the top of his hand.The brace was reportedly not being worn at that time.A towel, secured by tape, was placed over the skin area and topical benadryl was applied.The consumer consulted a doctor.The doctor reportedly advised the consumer he experienced an allergic reaction to the brace.The doctor prescribed a triamcinolone 1% steroid cream and prednisone.The consumer followed the prescribed treatment.The affected area improved.An alternative brand wrist support was purchased.

• Brand Name: ACE¿ DELUXE WRIST BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M COMPANY; 2510 conway avenue; st. paul,
• Manufacturer (Section G): DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD; lingxia village; liaobu town; dongguan guangdong, ; CH
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 9226419
• MDR Text Key: 163785593
• Report Number: 2110898-2019-00122
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 205276
• Device Lot Number: 8103E2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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: 65 YR