MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for NONE manufactured by .
[31796236]
I had an outpatient procedure called a pouchoscopy. Two days later i developed a high fever and was admitted to the hospital for septic shock. I spent 12 days at (b)(6) hospital in (b)(6). This included four days in icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057990 |
| MDR Report Key | 5240142 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-03-04 |
| Date Added to Maude | 2015-11-20 |
| 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 |
| Generic Name | NONE |
| Product Code | GCQ |
| Date Received | 2015-11-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2015-11-17 |