MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-12-06 for BODYMEDIA FIT manufactured by Bodymedia, Inc..
[3310890]
The complainant reported the following information. She had experienced pain in her upper left arm and stopped wearing the armband for a couple of days. The pain worsened to the point that she could not bend or straighten the arm. She went to an emergency room on (b)(6) 2012, where she was reportedly diagnosed with blood clots after an ultrasound and several scans. She reported that the cephalic and brachial veins were blocked. She was prescribed a blood thinner. She reported that it was a localized blood clot, not systemic, and would clear up after 3-4 months. She reported that the emergency room staff noted that the clot was in an unusual place and would likely have resulted from direct contact, impact or injury. She reported that she did not have an injury. She then reported that after showing the armband to the emergency room staff, they said it must have been the cause, because that was the only thing that made sense. She also reported having a full ct scan and going to the emergency room for two additional visits, both unrelated to the blood clot. One visit was for a cough and she did not mention the reason for the third visit. She reported that she had been coughing for a long time. As a result of starting a blood thinner, she was told to discontinue her migraine medication and had suffered a migraine since the emergency room visit which caused her to lose a whole day. She mentioned that her blood pressure could no longer be taken on her left arm. When asked, she reported that she was not wearing the armband too tightly. Upon requesting that the armband be returned, the complainant reported that there was nothing wrong with the armband and that it was working properly. Medical records and return of the armband have been requested multiple times, but have not been provided.
Patient Sequence No: 1, Text Type: D, B5
[10424131]
The sensewear armband ((b)(4) fit branded version) collects data to report information such as steps taken, calorie expenditure and physical activity duration to users. The user guide instructs users to adjust the strap, so it fits on the arm comfortably and advises if the user feels constriction or loss of circulation at any time, the adjustable strap should be loosened and re-fastened to a more comfortable setting. Upon internal review, the (b)(4) data for the complainant showed that complainant began wearing the armband in (b)(6) 2011. However, in the 60 days prior to the emergency room visit the complainant had worn it infrequently and the information she reported regarding her usage was inconsistent with the (b)(4) data. Additional usage information has been requested from the complainant. The information provided does not reasonably suggest that there was a product malfunction. It has been determined that no field actions are required at this time regarding this issue. If relevant information is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005662933-2012-00001 |
| MDR Report Key | 2913825 |
| Report Source | 04 |
| Date Received | 2012-12-06 |
| Date of Report | 2012-12-06 |
| Date of Event | 2012-11-04 |
| Date Mfgr Received | 2012-11-08 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2013-01-15 |
| 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 Street | 420 FT. DUQUESNE BLVD ONE GATEWAY CENTER |
| Manufacturer City | PITTSBURGH PA 15222 |
| Manufacturer Country | US |
| Manufacturer Postal | 15222 |
| Manufacturer Phone | 4122889901 |
| Manufacturer G1 | CREATION TECHNOLOGIES |
| Manufacturer Street | 110 CLEGG RD |
| Manufacturer City | MARKHAM, ON L6G1E1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L6G 1E1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BODYMEDIA FIT |
| Generic Name | IKK - SENSEWEAR ARMBAND |
| Product Code | IKK |
| Date Received | 2012-12-06 |
| ID Number | PART NO. 100759 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BODYMEDIA, INC. |
| Manufacturer Address | PITTSBURGH PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-12-06 |