MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-23 for BACKJOY CORE manufactured by Backjoy Core.
[16169141]
On (b) (6) 2009, i purchased a product known as the backjoy after 3 months of using this product. I was hospitalized with blood clots in the left leg and in the lung. I remained in icu for 7 days (b) (6) 2010, until (b) (6) 2010 at (b) (6) hospital, (b) (6). I have had any problem in this manner until i purchased this product. Medical problems - pulmonary thrombo embolism and atrial fibrillation and pneumonia. I will have to take coumadin for next 6 month to 1 year, along with other medication. Dates of use: (b) (6) 2009 - (b) (6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015288 |
| MDR Report Key | 1642745 |
| Date Received | 2010-03-23 |
| Date of Report | 2010-03-23 |
| Date of Event | 2010-03-04 |
| Date Added to Maude | 2010-04-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACKJOY CORE |
| Generic Name | ORTHOTIC SIT |
| Product Code | IPY |
| Date Received | 2010-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BACKJOY CORE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2010-03-23 |