MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for ECHOCARDIOGRAM TRANSESOPHAGEAL manufactured by Unknown.
[177601128]
Getting echocardiogram transesophageal became allergic, had to get bagged and used methyl blue. Test at (b)(6) hospital doctor (b)(6). Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092706 |
| MDR Report Key | 9659266 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-24 |
| Date Added to Maude | 2020-02-03 |
| 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 | 3 |
| Brand Name | ECHOCARDIOGRAM TRANSESOPHAGEAL |
| Generic Name | TRANSDUCER ULTRASONIC |
| Product Code | JOP |
| Date Received | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-31 |