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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.

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Type of DeviceCORE ARMBAND
Manufacturer (Section D)
pittsburgh PA
Manufacturer Contact
craig cuffie
one gateway ctr.
420 ft. duquesne blvd.
pittsburgh, PA 15222
MDR Report Key3783995
MDR Text Key4379915
Report Number3005662933-2014-00001
Device Sequence Number1
Product Code IKK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number100763
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/27/2014
Is The Reporter A Health Professional? No
Date Manufacturer Received03/18/2014
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

Date Received: 04/15/2014 Patient Sequence Number: 1