MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for RUTNER G17320 081914 manufactured by Cook Incorporated.
[102218801]
Patient Sequence No: 1, Text Type: N, H10
[102218802]
Pt had suprapubic catheter placed in or. Patient went home that day, and catheter fell out the same evening. Patient presented to urology clinic the following day with the catheter. Balloon was tested in clinic by the provider who placed the device and found to have a leak. Suprapubic catheter was sequestered. Package from this catheter was no longer available, so lot number is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7333741 |
| MDR Report Key | 7333741 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-12-12 |
| Report Date | 2018-03-02 |
| Date Reported to FDA | 2018-03-02 |
| Date Reported to Mfgr | 2018-03-02 |
| Date Added to Maude | 2018-03-13 |
| 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 | 3 |
| 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 | 3 |
| Brand Name | RUTNER |
| Generic Name | CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-03-13 |
| Model Number | G17320 |
| Catalog Number | 081914 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-13 |