MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-13 for MALECOT CATHETER SILICONE 12 FR UNK manufactured by Cook Medical.
[20657030]
Pt is a (b)(6) year old male with a history of recent bladder neck reconstruction on (b)(6) 2014. He was admitted on (b)(6) 2014 for endoscopic eval. He had some leakage from his midline incision. He was taken to the operating room on (b)(6) 2014 for removal of all tubes and drains that were placed on (b)(6) 2014. When the 12 french malecot catheter was removed the tip was missing. A cystoscopy was done and the missing tip was not in the bladder. A small incision was made and an exploratory lap was preformed to look for the tip between the bladder and abdominal wall. It could not be located. An x-ray was also taken which did not show the missing tip. It is not radiopaque.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4034917 |
| MDR Report Key | 4034917 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-11 |
| Date of Event | 2014-08-04 |
| Date Facility Aware | 2014-08-04 |
| Report Date | 2014-08-12 |
| Date Reported to FDA | 2014-08-12 |
| Date Reported to Mfgr | 2014-08-12 |
| Date Added to Maude | 2014-08-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALECOT CATHETER |
| Generic Name | MALECOT CATHETER |
| Product Code | FEW |
| Date Received | 2014-08-13 |
| Model Number | SILICONE 12 FR |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-13 |