MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-02-06 for SILICONE MALECOT CATHETER 083810 manufactured by Cook Urological Inc.
[3137719]
The urologist removed the cystostomy catheter and noted that the tip of the catheter was missing/retained in the bladder. The retained tip was confirmed after x-rays. The pt is scheduled for cystoscopy to remove the tip. (b)(6) 2013 - confirmed with customer, the broken piece was removed from the pt and the pt did fine during procedure. And confirmed pt to date is doing well.
Patient Sequence No: 1, Text Type: D, B5
[10436229]
Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00062 |
| MDR Report Key | 2954269 |
| Report Source | 00 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-01-10 |
| Date of Event | 2012-12-06 |
| Date Facility Aware | 2012-12-06 |
| Report Date | 2013-01-10 |
| Date Reported to FDA | 2012-12-01 |
| Date Mfgr Received | 2013-01-15 |
| Date Added to Maude | 2013-02-12 |
| 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 | SILICONE MALECOT CATHETER |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2013-02-06 |
| Model Number | NA |
| Catalog Number | 083810 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2013-02-06 |