FDA Adverse Event
Other
Summary report: N
BRAINLAB
MDR report key: 510575
·
Received January 28, 2004
Report
- Report Number
- MW1031001
- Event Type
- Other
- Date Received
- January 28, 2004
- Date of Event
- January 20, 2004
- Report Date
- January 28, 2004
- Manufacturer
- BRAINLAB GERMANY
- Product Code
- MUJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ON RESECTION OF SINUS TISSUE NOTICED ORBITAL FAT PROTRUDING FROM SOCKET INTO SINUS CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAINLAB | VECTOR VISION COMPACT | MUJ | BRAINLAB GERMANY | VECTOR VISION | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other | (1) SURGICAL INSTRUMENTS. (2) ANESTHESIA.| (3) ROUTINE SUPPLIES FOR SINUS SURGERY. |