MAUDE Adverse Event Report: BODYMEDIA, INC. BODYMEDIA FIT; CORE ARMBAND

Catalog Number 100763

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Cancer (3262)

Event Date 04/01/2013

Event Type  Injury  

Event Description

The customer reported the following information.The customer explained that she began using the device on (b)(6) 2013 on her left arm.She wore the device for approximately 20 hours a day and never cleaned the device.She was unaware that the device was supposed to be cleaned.A sore developed on her left arm in approximately (b)(6) 2013.At that time, she switched the device to her right arm.After several weeks of use, a sore developed on her right arm.Once this sore developed on her right arm (around (b)(6) 2013), she stopped using the device.The original sore on her left arm never healed with a crusty scab, even though she treated it with neosporin.On (b)(6) 2014, the customer visited her dermatologist for her annual checkup and the dermatologist was concerned with the sore on her left arm.The sore was biopsied by the dermatologist and it was determined to be basal cell carcinoma.The carcinoma was removed on (b)(6) 2014.The customer reported that she is diabetic.The device was returned to bodymedica for investigation.

Manufacturer Narrative

The bodymedia fit armband collects user data such as steps taken, calorie expenditure and physical activity duration.The user guide instructs users to discontinue use and consult a physician if irritation or redness occurs.Users are instructed not to wear the armband on an open wound, sore or burn.Users with known metal allergies are instructed to consult their physician prior to use.The user manual also instructs the user to clean the armband regularly.The returned device was investigated and verified to be functioning properly within specification.It was noted during visual inspection of the unit, that there was dirt on the device and it appeared to have not been cleaned per the user manual.During a phone conversation with the complainant, she verified that she had never cleaned the device per the user guide while using the device.The complainant also did not follow the user guide instructions for discontinuing use of the device and consulting a physician if an irritation occurs.Bodymedia requested review of this event and the pathology report by an independent dermatologist.In his expert opinion, the bodymedia fit armband did not cause the basal cell carcinoma to develop on the complainant's left arm.He further clarified that the latency for a basal cell carcinoma is many years and the complainant only wore the bodymedia device on her left arm for approximately 4-5 months.

• Brand Name: BODYMEDIA FIT
• Type of Device: CORE ARMBAND
• Manufacturer (Section D): BODYMEDIA, INC.; pittsburgh PA
• Manufacturer Contact: craig cuffie ; one gateway ctr.; 420 ft. duquesne blvd.; pittsburgh, PA 15222 ; 4152307624
• MDR Report Key: 3783995
• MDR Text Key: 4379915
• Report Number: 3005662933-2014-00001
• Device Sequence Number: 1
• Product Code: IKK
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 100763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 72 YR