FDA Adverse Event
Other
Summary report: N
LASE
MDR report key: 535281
·
Received March 9, 2004
Report
- Report Number
- 2183911-2004-00001
- Event Type
- Other
- Date Received
- March 9, 2004
- Report Date
- March 8, 2004
- Manufacturer
- CLARUS MEDICAL, LLC.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ABOUT 2 MONTHS AGO THE PHYSICIAN PERFORMED A LASER PROCEDURE ON A PT WHO NOW HAS DEVELOPED A REGIONAL PAIN SYNDROME. THE PT DID FINE INITIALLY AND THEN DEVELOPED PAIN STARTING AT ABOUT 5 DAYS. THE PHYSICIAN THINKS THE ONSET OF THE PAIN IS ASSOCIATED WITH THE LASE PROCEDURE BUT NOT CAUSED BY A DEFECT IN THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE MULTI LEVEL PROCEDURE LASTED SEVERAL HOURS, THAT HE HAD TREATED THIS SYNDROME BEFORE AND FELT COMFORTABLE THAT HE KNOW HOW TO TREAT IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASE | ENDOSCOPIC DISCETOMY DEVICE | GEX | CLARUS MEDICAL, LLC. | 1100-002 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |