FDA Adverse Event
Injury
Summary report: N
TELEMED CYTOLOGY BRUSH
MDR report key: 4533704
·
Received February 22, 2015
Report
- Report Number
- 1222168-2015-00001
- Event Type
- Injury
- Date Received
- February 22, 2015
- Date of Event
- January 21, 2015
- Report Date
- June 18, 2015
- Manufacturer
- TELEMED SYSTEMS INC.
- Product Code
- FDX
- PMA / PMN Number
- K901436
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS EXAMINED BY DR. (B)(6) ((B)(6)). THE DEVICE WAS INTACT WITH NO MISSING PIECES OR COMPONENTS. MECHANICAL FUNCTION OF BRUCH AND HANDLE WERE NORMAL AND FUNCTIONED ACCORDING TO MANUFACTURING SPECIFICATIONS; NO DEVICE MALFUNCTION WAS DETECTED.
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED ON 2/19/2015; NO EVALUATION PERFORMED YET. WILL FILE FOLLOW-UP REPORT WITH RESULTS OF EVALUATION.
Description of Event or Problem · 1
PATIENT DEVELOPED PNEUMOTHORAX SUBSEQUENT TO ENDOSCOPIC USE OF CYTOLOGY BRUSH TO OBTAIN SAMPLE FROM RIGHT LUNG.
Description of Event or Problem · 1
PATIENT DEVELOPED PNEUMOTHORAX SUBSEQUENT TO ENDOSCOPIC USE OF CYTOLOGY BRUSH TO OBTAIN SAMPLE FROM RIGHT LUNG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124852 | TELEMED CYTOLOGY BRUSH | CVYTOLOGY BRUSH | FDX | TELEMED SYSTEMS INC. | 3014 | K13683104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | BRONCHOSCOPE |