FDA Adverse Event
Malfunction
Summary report: N
COOLSCULPTING ELITE SYSTEM
MDR report key: 12403930
·
Received September 1, 2021
Report
- Report Number
- 3007215625-2021-01560
- Event Type
- Malfunction
- Date Received
- September 1, 2021
- Date of Event
- August 2, 2021
- Report Date
- April 15, 2025
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K183514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTED DATA: B5, D1, D4, G1.
Description of Event or Problem · 0
UPON FURTHER REVIEW OF THE REPORTED EVENT, THE EVENT IS NOT REPORTABLE.
Additional Manufacturer Narrative · 1
A TECHNICAL INVESTIGATION SHOWED THAT THE SYSTEM INCORRECTLY REPORTED Z 920-407 ERROR DURING TREATMENT RATHER THAN A THERMAL EVENT WARNING WHICH DISPLAYS AS Z 409-383. BASED ON THE INFORMATION CURRENTLY AVAILABLE AND TECHNICAL REVIEW, ALTHOUGH NO ADVERSE EVENT WAS REPORTED, THE DISPLAY OF THE WRONG ERROR CODE BY THE SYSTEM RATHER THAN THE CORRECT THERMAL CODE, MAY LEAD TO A SERIOUS THIRD-DEGREE BURN IF THE MALFUNCTION WERE TO RECUR. FURTHER INVESTIGATION IS BEING PERFORMED.
Description of Event or Problem · 1
ALLERGAN AESTHETICS RECEIVED A REPORT Z920-406 LOG SERVICE HAS EXITED WITH THEIR ELITE CURVE 150 APPLICATOR. Z920-406 IS NOT LISTED AND THE PATIENT WAS RETREATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1307505 | COOLSCULPTING ELITE SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |