FDA Adverse Event
Other
Summary report: N
BERCHTOLD CHROMOPHARE
MDR report key: 409553
·
Received August 2, 2002
Report
- Report Number
- 1220685-2002-00002
- Event Type
- Other
- Date Received
- August 2, 2002
- Date of Event
- April 24, 2002
- Manufacturer
- BERCHTOLD CORP.
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN OPERATIVE PROCEUDRE, THE SURGEON ALIGNING THE OVERHEAD LIGHT BUMPED THE BASE OF THE CENTRAL COLUMN WITH LIGHT HOUSING. PAINT FLECKS FELL OFF THE CENTRAL COLUMN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BERCHTOLD CHROMOPHARE | LIGHT. SURGICAL. DUAL HEAD | FSY | BERCHTOLD CORP. | C570570D | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |