MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for ULTRASOUND manufactured by Unk.
[131545907]
I had an extensive ultrasound check of the abdomen with my general practitioner (in (b)(6)) yesterday morning and that evening i had sudden, unusual pain in the exact areas he concentrated on. It was a different kind of pain than any other abdominal pain i've had before and differently distributed. My abdomen feels bloated and somehow wounded. I don't think it's because of what i ate. I've never experienced pain after ultrasound before but this examination was prolonged and involved two different heads on the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082525 |
| MDR Report Key | 8191726 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-19 |
| Date Added to Maude | 2018-12-21 |
| 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 | ULTRASOUND |
| Generic Name | ULTRASOUND |
| Product Code | MUI |
| Date Received | 2018-12-20 |
| Device Availability | N |
| 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. Deathisabilit | 2018-12-20 |