MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for COOK MEDICAL FUHRMAN PLEURAL PNEUMOPERICARDIAL TUBE G55713 manufactured by Cook Inc..
[78148479]
Upon removal of the chest tube, fragments of the tube remained in the baby's chest requiring surgical removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070536 |
| MDR Report Key | 6656833 |
| Date Received | 2017-06-19 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-06-15 |
| Date Added to Maude | 2017-06-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | COOK MEDICAL FUHRMAN PLEURAL PNEUMOPERICARDIAL TUBE |
| Generic Name | CHEST TUBE |
| Product Code | OFA |
| Date Received | 2017-06-19 |
| Catalog Number | G55713 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-06-19 |