MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-18 for JACKSON PRATT CARDIOTORACIC DRAIN manufactured by Evco Plastics, Div. Don Evans, Inc.
[49755044]
Patient Sequence No: 1, Text Type: N, H10
[49755045]
Nurse practitioner removed jp drain from patient. She then advised primary rn that patient would need stat ct head to evaluate for possible retained drain fragment. Patient taken to surgery and drain fragment was removed. Patient condition remained same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5801815 |
| MDR Report Key | 5801815 |
| Date Received | 2016-07-18 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-17 |
| Report Date | 2016-07-06 |
| Date Reported to FDA | 2016-07-06 |
| Date Reported to Mfgr | 2016-07-06 |
| Date Added to Maude | 2016-07-18 |
| 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 | JACKSON PRATT CARDIOTORACIC DRAIN |
| Generic Name | CONNECTOR, CATHETER |
| Product Code | GCD |
| Date Received | 2016-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EVCO PLASTICS, DIV. DON EVANS, INC |
| Manufacturer Address | 121 EVCO CIRCLE DEFOREST 53532 WI 53532 US 53532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-07-18 |