MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-19 for SILICONE MALECOT CATHETER 083812 manufactured by Cook Urological Inc.
[21949906]
Expiration - unk as lot is unk. Unk as lot is unk. (b)(4). . Event eval: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[22041606]
The tip got separated. The entire tip separated and the pt was taken to the operating room to have the tip removed. Tip separation occurred outside the bladder. No additional info has been provided by the reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2013-00277 |
| MDR Report Key | 3245703 |
| Report Source | 06 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-06-20 |
| Date of Event | 2013-06-17 |
| Date Facility Aware | 2013-06-17 |
| Report Date | 2013-06-20 |
| Date Mfgr Received | 2013-06-24 |
| Date Added to Maude | 2013-07-25 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIR |
| 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 | 2013-07-19 |
| Returned To Mfg | 2013-07-03 |
| Model Number | NA |
| Catalog Number | 083812 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| 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. Required No Informationntervention | 2013-07-19 |