MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-25 for INFUSE BONE GRAFT DEVICE (RH BMP-2) manufactured by Medtronic Inc..
[19578458]
Infused used during my surgery caused me to have bone overgrowth which forced me to have more surgery. I have been diagnosed with arachnoiditis and have also suffered from an infection that required 2 months of iv antibiotic use. I also have severe daily. Pain and neuropathies infuse was used off label without my consent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030697 |
| MDR Report Key | 3195857 |
| Date Received | 2013-06-25 |
| Date of Report | 2013-04-11 |
| Date of Event | 2010-10-16 |
| Date Added to Maude | 2013-07-01 |
| 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 | 3 |
| 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 | INFUSE BONE GRAFT DEVICE (RH BMP-2) |
| Generic Name | INFUSE |
| Product Code | MPW |
| Date Received | 2013-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2013-06-25 |