MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for SILICONE THORACIC CATHETER 28FR 8888572552 manufactured by Covidien.
[61049480]
Physician was removing the chest tube and part of the chest tube remained in the patient. Patient had to return to surgery for a thoracoscopy and removal of foreign body. Chest tube piece was retrieved and sent to pathology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066356 |
| MDR Report Key | 6129001 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-04 |
| Date Added to Maude | 2016-11-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SILICONE THORACIC CATHETER 28FR |
| Generic Name | SILICONE THORACIC CATHETER 28FR |
| Product Code | GBS |
| Date Received | 2016-11-23 |
| Catalog Number | 8888572552 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD ME 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-23 |