MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-02-08 for PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET 082010-ET manufactured by Cook Urological Inc..
[17325437]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[17342905]
The pt had continuous vesical bleeding and frequent occlusions of urethral catheter has been observed. Frequent blood transfusions were performed. On (b)(6) 2012, nephrostomy was performed and two 082010-et were placed on each side. No damage was confirmed on both catheters. The procedure was completed without notable problem. On (b)(6) 2012, no breakage on the catheters was confirmed by kub. On (b)(6) 2013, no breakage on the catheters was confirmed by ct. On (b)(6) 2012, urine leakage from where the catheter was inserted in the left was confirmed. On (b)(6) 2012, separation of the catheter tip in the left was confirmed. The catheters in both sides were replaced with balloon catheters. The separated catheter tip remained in the left kidney pelvis. Additional information provided on (b)(6) 2013: removal of the catheter tip from the pt will not be planned. The pt has not shown any problematic symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2013-00077 |
| MDR Report Key | 2958242 |
| Report Source | 01,08 |
| Date Received | 2013-02-08 |
| Date of Report | 2013-01-11 |
| Date of Event | 2013-01-08 |
| Date Facility Aware | 2013-01-08 |
| Report Date | 2013-01-11 |
| Date Mfgr Received | 2013-01-21 |
| Date Added to Maude | 2013-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET |
| Generic Name | KOB CATHETERM SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2013-02-08 |
| Returned To Mfg | 2013-01-29 |
| Model Number | NA |
| Catalog Number | 082010-ET |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-08 |