MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for CORTRAK ENTERAL ACCESS SYSTEM manufactured by Corpak Medsystems.
[42409928]
Patient Sequence No: 1, Text Type: N, H10
[42409929]
Patient with 40% total burn size (tbs) flame burn was intubated and sedated with cortrak feeding device. Recognized that something was wrong with it when the tube feeds started to come out of his mouth. The cortrak was removed and discovered to be severed, leaving approximately 2/3 of the distal end in the patient's stomach. The fragment was removed at the beside by gi procedures two days after the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5569515 |
| MDR Report Key | 5569515 |
| Date Received | 2016-04-12 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-03-22 |
| Report Date | 2016-03-30 |
| Date Reported to FDA | 2016-03-30 |
| Date Reported to Mfgr | 2016-03-30 |
| Date Added to Maude | 2016-04-12 |
| 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 | CORTRAK ENTERAL ACCESS SYSTEM |
| Generic Name | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | FFW |
| Date Received | 2016-04-12 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPAK MEDSYSTEMS |
| Manufacturer Address | 1001 ASBURY DRIVE BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-12 |