FDA Adverse Event
Injury
Summary report: N
LASE
MDR report key: 3023792
·
Received March 22, 2013
Report
- Report Number
- 2183911-2013-00001
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- March 1, 2011
- Report Date
- March 18, 2013
- Manufacturer
- CLARUS MEDICAL, LLC.
- Product Code
- GEX
- PMA / PMN Number
- K040424
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PROBLEM WITH THE DEVICE OR PROCEDURE WERE REPORTED BY THE SALES REP, HOSPITAL, OR ATTENDING PHYSICIAN. CLARUS MEDICAL BECAME FIRST AWARE OF POTENTIAL PT INJURY WHEN NOTIFIED BY SUMMONS. NO DEVICE HAS BEEN RETURNED FOR EVAL. IN ADDITION, THE LASE DEVICE IS SOLD FOR USE WITH HO:YAG LASER. INJURY CLAIMED WAS WITH LASE DEVICE AND KTP LASER. OUR RECORDS INDICATE DEVICES SHIPPED TO THAT HOSPITAL CANNOT BE ATTACHED TO KTP LASER. THE CONNECTIONS ARE INCOMPATIBLE.
Description of Event or Problem · 1
CLARUS MEDICAL WAS NOTIFIED ON (B)(4) 2013 BY SUMMONS. THE CLAIM IS THE PT WAS INJURED BY "THERMAL INJURY." CLARUS MEDICAL WAS FIRST AWARE OF THIS POTENTIAL ADVERSE EVENT ON (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119215 | LASE | LASER DISCECTOMY CATHETER | GEX | CLARUS MEDICAL, LLC. | 1100-010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LASERSCOPE, MODEL 814, KTP-YAG LASER, (B)(6) 2011 |