FDA Adverse Event
Injury
Summary report: N
MEDICAL INNOVATIONS CORP
MDR report key: 120765
·
Received September 17, 1997
Report
- Report Number
- 120765
- Event Type
- Injury
- Date Received
- September 17, 1997
- Date of Event
- April 30, 1997
- Report Date
- September 8, 1997
- Manufacturer
- MEDICAL INNOVATIONS CORP
- Product Code
- BTG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PLASTIC TIP OF DISPOSABLE CYTOLOGY BRUSH FELL OFF DURING BROCHOSCOPY. PATIENT REQUIRED SECOND OUTPATIENT BRONCHOSCOPY TO REMOVED TIP FROM PATIENT'S LUNG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDICAL INNOVATIONS CORP | DISPOSABLE CYTOLOGY BRUSH | BTG | MEDICAL INNOVATIONS CORP | * | 6112-7902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |