MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for SHILEY 125037 manufactured by Mallinckrodt Medical.
[183109071]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183109072]
According to the reporter, the unit had unknown failure. It was stated that tracheal and left bronchie tears were detected a few days after surgery due to the deteriorated health of the patient, bronchofiberoscopy was performed where the nodules were detected. It was indicated that the patient encountered pneumothorax, worse general condition after surgery and difficulties with breathing. Medicines were given and extended patient hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020889-2020-00016 |
| MDR Report Key | 9783100 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT MEDICAL |
| Manufacturer Street | CORNAMADDY |
| Manufacturer City | ATHLONE 3810 |
| Manufacturer Country | IE |
| Manufacturer Postal Code | 3810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILEY |
| Generic Name | TUBE, BRONCHIAL (W/WO CONNECTOR) |
| Product Code | BTS |
| Date Received | 2020-03-03 |
| Model Number | 125037 |
| Catalog Number | 125037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MEDICAL |
| Manufacturer Address | CORNAMADDY ATHLONE 3810 IE 3810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-03 |