MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-18 for REVEALER UNK manufactured by Unk.
[17516002]
Rptr was referred to a vascular surgeon and a cardiologist because of blood pressure problems. The vascular surgeon implanted device. After implantation rptr could feel it "tearing inside" and had extreme pain inside their breast. Rptr thought their breast implants were ruptured. The device was removed 2 weeks later. Rptr activated device twice and then the 3rd time they had to go to the dr. At that time they found out the mfr reads the device, not their physician. Rptr didn't realize mfr reps were that involved and in the or when device was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026789 |
| MDR Report Key | 428791 |
| Date Received | 2002-11-18 |
| Date of Report | 2002-11-18 |
| Date of Event | 2002-08-01 |
| Date Added to Maude | 2002-11-25 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVEALER |
| Generic Name | HEART + BP MONITOR IMPLANTABLE |
| Product Code | DXH |
| Date Received | 2002-11-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 417814 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-11-18 |