FDA Adverse Event
Injury
Summary report: N
GENTLELASE PRO
MDR report key: 2516396
·
Received March 29, 2012
Report
- Report Number
- 1218402-2012-00004
- Event Type
- Injury
- Date Received
- March 29, 2012
- Date of Event
- February 23, 2012
- Report Date
- March 29, 2012
- Manufacturer
- CANDELA CORP.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE UNIT THAT WAS USED FOR THIS TREATMENT WAS A DEMO AND WAS INSTALLED AT THE USER SITE JUNE 18, 2011. THERE HAVE BEEN NO CLINICAL COMPLAINTS REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WERE REVIEWED 3/23/2012 WITH NO CONCLUSIONS MADE. UPON REVIEW BY THE CANDELA CLINICAL MANAGER, IT WAS SUGGESTED THAT THE SELECTED PATIENT HAD A SKIN TYPE THAT WAS TOO DARK FOR THIS TYPE OF TREATMENT. A CANDELA FIELD SERVICE ENGINEER INSPECTED THE UNIT INVOLVED IN THE EVENT AND REPORTED THAT THE UNIT WAS OPERATING WITHIN SPECIFICATION.
Description of Event or Problem · 1
A PATIENT IN (B)(6) RECEIVED A TREATMENT FOR PIGMENTED LESIONS ON THE FACE AND RESPONDED WITH HYPER PIGMENTATION AND BURNS ON THE TREATED AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENTLELASE PRO | DERMATOLOGY LASER | GEX | CANDELA CORP. | 9914-00-9015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |