MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO(TM) SPORT TENNIS ELBOW SUPPORT; ORTHOSIS, LIMB BRACE

Model Number N/A

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

Patient Problem Cellulitis (1768)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Expiration date and lot number not applicable.Device manufacture date is identified by an alpha code which represents the year 2016.The consumer stated that she continued to wear the support an additional 3 days after skin irritation noted.The product packaging contains the statement "if discomfort or pain results, persists or increases, discontinue use and consult a physician." customer misuse is probable.The customer did not specify the size of the arm on which she wore the support.It is not known if the support was properly fit to the arm.Evaluation of the returned product showed no abnormalities with the exception of a slight stain visible on the tendon pad of the product.This is consistent with use of a topical cream or ointment by the consumer.End of report.

Event Description

A female customer wore the referenced elbow support continuously for 2 days.She alleged the area under the support began to itch.She removed the support at bedtime.She wore the support during the day for 3 additional days.She alleged hives, red bumps, and itch at the inside bend of her elbow.The woman applied over-the-counter topical benadryl (diphenhydramine) and stopped wearing the support.After two days she alleged the area remained red, bumpy, and itchy and kept her awake at night.She applied ice to the area.The woman alleged that her elbow became infected and that the infection spread on her arm.She saw a doctor whom she alleged prescribed unspecified steroids and antibiotics.Additional information received (b)(6) 2016 - the customer submitted paperwork which confirmed that she was seen by her doctor on (b)(6) 2016.She was diagnosed with an allergic reaction and cellulitis in the area where the brace was worn.

• Brand Name: FUTURO(TM) SPORT TENNIS ELBOW SUPPORT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY - CONSUMER HEALTH CARE; 910 lila avenue; milford OH 45150
• Manufacturer Contact: becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 6115083
• MDR Text Key: 60424481
• Report Number: 2110898-2016-00105
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 45975
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other