MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-03-07 for NONE manufactured by .
[2630899]
Subject was hospitalization on (b)(6) 2012 with symptoms of jaundice and abdominal pain that started on (b)(6) 2012. Presumed transient bacteremia following ercp. Per pt, following ercp on (b)(6) 2012, he began to have worsening abdominal pain, predominantly in the right upper quadrant. He reported the pain as throbbing, nonradiating, that was constant but no associated nausea or vomiting. He reports that 4 to 5 days following the onset of pain, he then noticed dark urine, as well as increasing yellowing of his eyes with associated pruritus. He presented to his local emergency room in (b)(6), at which time, he was noted to have elevated liver tests and was thus transferred for further eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2484594 |
| MDR Report Key | 2484594 |
| Report Source | 99 |
| Date Received | 2012-03-07 |
| Date of Report | 2012-01-26 |
| Date of Event | 2012-01-15 |
| Date Facility Aware | 2012-01-24 |
| Report Date | 2012-01-26 |
| Date Reported to FDA | 2012-01-30 |
| Date Added to Maude | 2012-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | ODD |
| Date Received | 2012-03-07 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-03-07 |