MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for BONE MORPHOGENETIC PROTEIN (BMP) manufactured by Unk.
[143460730]
I had an adverse reaction to the bmp used during my 2008 cervical disc fusion. The off label dose of bmp caused swallowing problems, breathing problems and lumbar spine tumors first appeared on mri 2013 (b)(6). I need the fda to investigate on my behalf. Dr (b)(6) knowingly used a product that was not fda approved. Dr (b)(6) lied to me about the safety of this chemical that he allowed to enter my spinal fluid where he tore a hole in my spinal cord at c7. Dr (b)(6) tried to cover his mistakes up from the first surgery, he botched and made my spinal and other health substantially worse. I can never be made whole again. He jeopardized my life and must be held accountable. Please help me. I need this confirmed once and for all. He never bothered to say he was sorry. Was this device serviced by a third party servicer? Yes. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086220 |
| MDR Report Key | 8555752 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-24 |
| Date of Event | 2008-09-18 |
| Date Added to Maude | 2019-04-26 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE MORPHOGENETIC PROTEIN (BMP) |
| Generic Name | FILTER, RECONBINANT HUMAN BONE MORPHOGENETIC PROTEN CALLAGEN SCAFFOLD W/METAL PR |
| Product Code | NEK |
| Date Received | 2019-04-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2019-04-25 |