MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-14 for SUPERDIMENSION SDTNB1500 manufactured by Covidien Lp - Superdimension Inc.
[69857834]
The device was not returned for evaluation. The incoming inspection record was reviewed and there were no anomalies observed associated to this issue. Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.
Patient Sequence No: 1, Text Type: N, H10
[69857835]
A patient was identified with pneumothorax post superdimension enb procedure. The patient was admitted to inpatient and a chest tube was placed.
Patient Sequence No: 1, Text Type: D, B5
[109378667]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004962788-2017-05021 |
| MDR Report Key | 6402159 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-14 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2017-03-14 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 161 CHESHIRE LANE SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERDIMENSION |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2017-03-14 |
| Model Number | SDTNB1500 |
| Catalog Number | SDTNB1500 |
| Lot Number | SD05-16-011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP - SUPERDIMENSION INC |
| Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-03-14 |