MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-17 for A-TRAUM 28 FRENCH THORACIC SILICONE CATHETER manufactured by Axiom Medical, Inc.
[3929388]
Pt had thoracotomy procedure on (b)(6) 2013. Post-operatively, chest tube was pulled, without notice the entire tube was not intact. On (b)(6) 2013, original surgeon reported retained chest tube. On (b)(6) 2013, approx 7" piece of tube was surgically removed without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031917 |
| MDR Report Key | 3362426 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-09-16 |
| Date of Event | 2013-07-15 |
| Date Added to Maude | 2013-09-24 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A-TRAUM 28 FRENCH THORACIC SILICONE CATHETER |
| Generic Name | THORACIC CATHETER |
| Product Code | GBS |
| Date Received | 2013-09-17 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AXIOM MEDICAL, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-09-17 |