MAUDE Adverse Event Report: 3M HEALTH CARE FUTURO TENNIS ELBOW SUPPORT; 890.3475 LIMB ORTHOSIS

Catalog Number 45975EN

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

Patient Problem Irritation (1941)

Event Date 06/17/2014

Event Type  Injury  

Event Description

The customer is calling because she has a black sports tennis elbow brace and it has caused a 3rd degree burn mark that is the same size as the pad on the brace.She has pictures and has gone to the doctor about it.The skin at the point on the pad has removed the skin completely.The 2nd day 5pm-9pm when the brace was on her elbow felt warm and fell asleep on the couch, but when she woke up, that is when she noticed it was burning, and once removed noticed it was red, brown like a burn the skin peeled off and customer stated, "looks like a 2nd/3rd degree burn it has taken off 2-3 layers of her skin." customer went to the doctor and doctor said it came from the brace.Customer put burn ointment on it (not sure of the name).Customer stated "her skin is now raw and down to three layers of skin she will need plastic surgery.".

Manufacturer Narrative

Skin irritation, no known device problem.Product was not returned to mfr, product was not returned for evaluation, no conclusion can be drawn.

• Brand Name: FUTURO TENNIS ELBOW SUPPORT
• Type of Device: 890.3475 LIMB ORTHOSIS
• Manufacturer (Section D): 3M HEALTH CARE; milford OH
• Manufacturer Contact: shawn busch ; 910 lila ave.; milford, OH 45150 ; 5132725077
• MDR Report Key: 3894128
• MDR Text Key: 17612811
• Report Number: 2110898-2014-00042
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 45975EN
• Device Lot Number: A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2014
• 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: Reuse
• Patient Sequence Number: 1