MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-01-27 for SILCON THORACIC CATH 28FR 8888572552 manufactured by Covidien.
[65941187]
Submit date: 1/27/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[65941188]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a thoracic catheter. The customer states that the physician was removing the chest tube and part of the chest tube remained in the patient. The patient had to return to surgery for a thoracoscopy to remove the foreign body. The piece of the chest tube was retrieved and sent to pathology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2017-00142 |
| MDR Report Key | 6282468 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-03 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2017-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILCON THORACIC CATH 28FR |
| Generic Name | THORACIC CATHETER |
| Product Code | GBS |
| Date Received | 2017-01-27 |
| Model Number | 8888572552 |
| 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 | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-27 |