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 .
[2549962]
The pt is a (b)(6) gentleman that had undergone ercp on (b)(6) 2011 for an anastomotic stricture. He was treated with balloon dilation and bile duct stent placement. During recovery, he was experiencing pain with amylase/lipase elevations. He was hospitalized, diagnosed with post ercp pancreatitis. Event unrelated to the placement of indwelling stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2484595 |
| MDR Report Key | 2484595 |
| Report Source | 99 |
| Date Received | 2012-03-07 |
| Date of Report | 2012-01-03 |
| Date of Event | 2011-12-28 |
| Date Facility Aware | 2012-01-03 |
| Report Date | 2012-01-03 |
| Date Reported to FDA | 2012-01-04 |
| 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 |