MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-15 for BODYMEDIA FIT 100763 manufactured by Bodymedia, Inc..
[4379915]
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.
Patient Sequence No: 1, Text Type: D, B5
[11878524]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005662933-2014-00001 |
| MDR Report Key | 3783995 |
| Report Source | 04 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-03-18 |
| Date of Event | 2013-04-01 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG CUFFIE |
| Manufacturer Street | ONE GATEWAY CTR. 420 FT. DUQUESNE BLVD. |
| Manufacturer City | PITTSBURGH PA 15222 |
| Manufacturer Country | US |
| Manufacturer Postal | 15222 |
| Manufacturer Phone | 4152307624 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BODYMEDIA FIT |
| Generic Name | CORE ARMBAND |
| Product Code | IKK |
| Date Received | 2014-04-15 |
| Returned To Mfg | 2014-03-27 |
| Catalog Number | 100763 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BODYMEDIA, INC. |
| Manufacturer Address | PITTSBURGH PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-15 |