MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-14 for SUPRAPUBIC TUBE manufactured by .
[2501615]
Pt had cystectomy in (b)(6) 2011 and was discharged on (b)(6) 2011 as scheduled. During pt's post-op office visit, it was stated this suprapubic tube was dislodged and drainage from incision. Admitted to the hospital for management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023490 |
| MDR Report Key | 2382525 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-11-14 |
| Date Added to Maude | 2011-12-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SUPRAPUBIC TUBE |
| Product Code | KOB |
| Date Received | 2011-12-14 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-12-14 |