MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-05-05 for GOWEAR FIT manufactured by Bodymedia, Inc..
[20954108]
Complainant wore a gowear fit armband for just over 48 hours. He reported a large blister under the armband and was advised by bodymedia to discontinue use and consult a physician. According to the complainant, on the fourth day after removing the armband, the left arm began to swell, became red and dripped fluids. The left leg began to swell similar to the arm, almost like a rash that was itchy. After a few days, complainant reported approx 50% improvement in swelling. Complainant then alleged, in addition to the previous claims, that a blood clot under the armband and two scars developed, and that after two and a half months the arm and leg were still inflamed. Complainant reported making six doctor visits and one hospital visit. Medical records from the physicians and/or health care providers were requested but have not been provided. The armband involved with this complaint was returned for refund and was evaluated by bodymedia. The armband passed testing with no faults found. There was nothing unusual noted regarding the armband. Add'l info has been requested. If info relevant to this complaint is obtained, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[21145838]
The sensewear armband (gowear fit branded version) collects data to report info such as steps taken, calorie expenditure and physical activity duration to users. The user guide instructs users to discontinue use and consult a physician if they experience irritation or redness after wear. 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 returned unit was verified to function properly. There is no indication that the reported events were life threatening, resulted in permanent impairment of a body function or permanent damage to a body structure, or required intervention to prevent permanent impairment or damage. Information regarding diagnosis, treatment, physicians and/or health care providers has not been provided to substantiate the claims made by the complainant. If relevant info is obtained, a f/u report will be submitted. No anomalies found with this unit. Sensors perform as designed, and are well within the (b)(4) pt exposure limits.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005662933-2011-00001 |
| MDR Report Key | 2092887 |
| Report Source | 04 |
| Date Received | 2011-05-05 |
| Date of Report | 2011-04-02 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-04-02 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2012-06-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 420 FORT DUQUESNE BLVD. STE 1900, ONE GATEWAY CENTER |
| Manufacturer City | PITTSBURGH PA 15222 |
| Manufacturer Country | US |
| Manufacturer Postal | 15222 |
| Manufacturer Phone | 4122889901 |
| Manufacturer G1 | MILLENNIA TECHNOLOGIES, INC. |
| Manufacturer Street | 1105 PITTSBURGH STREET |
| Manufacturer City | CHESWICK PA 15024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOWEAR FIT |
| Generic Name | IKK - SENSEWEAR ARMBAND |
| Product Code | IKK |
| Date Received | 2011-05-05 |
| Returned To Mfg | 2011-04-14 |
| ID Number | PART NUMBER 100510 |
| 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. Hospitalization | 2011-05-05 |