MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-15 for COOK UNK manufactured by Unk.
[463466]
Malecot catheter had been placed for drainage of left side empyema post rib resection. The catheter had been slowing advanced out by the cardiothoracic surgeon. Upon removal of catheter, the drain snapped open and a portion was retained. The pt was taken to the operating room where the drain was surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036629 |
| MDR Report Key | 734555 |
| Date Received | 2005-09-20 |
| Date of Report | 2005-09-15 |
| Date of Event | 2005-09-07 |
| Date Added to Maude | 2006-07-18 |
| 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 |
| 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 | COOK |
| Generic Name | MALECOT CATHETER |
| Product Code | FEW |
| Date Received | 2005-09-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 722443 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-20 |