MAUDE Adverse Event Report: 3M HEALTH CARE ACE¿ COMPRESSION CALF SLEEVE ; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problems Rash (2033); Swelling (2091); Reaction (2414)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

This product is exempt from udi.This product has no established expiry date.(b)(4).Root cause could not be determined with provided information.Product packaging lists the following: if discomfort or pain results, persists or increases, discontinue use and consult a physician.3m will continue to monitor.

Event Description

A mother reported her (b)(6)-year-old son wore the referenced compression calf sleeve on both legs.The product was washed prior to wear.No creams or lotions were applied to the skin prior to wear.The sleeves were worn twice during football practices on (b)(6) 2019.The sleeves were worn for approximately 2.5 hours each day.The mother alleged her son immediately experienced a reaction to the product during the first day of wear.She alleged the reaction occurred on both legs.The affected area was described as a red, puffy, bumpy and raised rash.The reaction reportedly went up each knee and progressed to the thighs.The mother alleged her son's feet swelled.She reported when the feet were pressed little marks were visible under the skin.The son reportedly has seasonal allergies.No other allergies were specified.Benadryl was taken after the second day of wear.The mother took her son to urgent care on (b)(6) 2019 due to no symptom improvement.The doctor reportedly advised her son had an allergic reaction to the product.The doctor prescribed a steroid, prednisone, and an antihistamine, hydroxyzine.The mother reported a red square, approximately 1"-inch size, was reportedly still visible on the boy's feet.She reported the affected area appeared to improve with treatment.

• Brand Name: ACE¿ COMPRESSION CALF SLEEVE
• 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 ; CH
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 9167000
• MDR Text Key: 161660477
• Report Number: 2110898-2019-00112
• 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
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 901510
• Device Lot Number: 8192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• 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 Age: 16 YR