COOLSCULPTING ELITE SYSTEM
Report
- Report Number
- 3007215625-2021-01625
- Event Type
- Injury
- Date Received
- September 16, 2021
- Date of Event
- August 26, 2021
- Report Date
- September 13, 2022
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K183514
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01625-00.
H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF PREVIOUS MW REPORTS, IT HAS BEEN IDENTIFIED THAT THERE IS NO THIRD DEGREE BURN.
CORRECTED DATA: D1.
REPORTED AE : SKIN-PEELING. RECEIVED A CALL FROM THE PROVIDER REPORTING BELOW RECEIVED DATE: 08/26/2021. CONTACT- CALLER NAME-PATIENT/PROVIDER AND TITLE: (B)(6). PATIENT INITIALS: (B)(6). TREATMENT DATE OR DATES: ON (B)(6) 2021. AREA(S) TREATED: LOWER ABDOMEN. DATE OF ONSET OF SYMPTOMS (WHEN PATIENT FIRST NOTICED): ON (B)(6) 2021. AREA(S) WITH SYMPTOMS: LOWER ABDOMEN. COOLSCULPTING SYSTEM SERIAL- UPM NUMBER: NOT IN THE OFFICE. APPLICATOR: CONTOUR, IF APPLICABLE: APPLICATOR SERIAL NUMBER: TREATMENT SETTINGS/TREATMENT PARAMETERS: (LEGACY APPLICATORS): GEL PAD/SYRINGE LOT NUMBER: DESCRIPTION OF EVENTS: 2 THERMAL EVENTS WITH THE ELITE AND RE-TREATED THE PATIENT WITH THE COOLADVANTAGE. ONCE SHE TOOK OFF THE COOLADVANTAGE APPLICATOR THE PATIENT SKIN IS BURNED AND PEELING. PROVIDER STATED THE PATIENT IS PEELING AND WANTS TO KNOW WHAT TO DO AND DOES NOT WANT TO PROVIDE ANY OTHER INFORMATION, ADVISED WE CAN NOT PROVIDE CLINICAL ASSESSMENTS NOR TREATMENT RECOMMENDATIONS TRANSFERRED TO MED INFO. (B)(6).
SUBSEQUENT TO THE SUBMISSION OF PREVIOUS MW REPORTS, IT HAS BEEN IDENTIFIED THAT THERE IS NO THIRD DEGREE BURN.
SUBSEQUENT TO THE SUBMISSION OF PREVIOUS MW REPORTS, IT HAS BEEN IDENTIFIED THAT THERE IS NO THIRD DEGREE BURN.
THE REPORTED EVENT IS IN THE PRODUCT LABELING AND FURTHER INVESTIGATION IS BEING PERFORMED.
ALLERGAN AESTHETICS RECEIVED A REPORT THAT FOLLOWING COOLSCULPTING TREATMENT PROCEDURES TO THE LOWER ABDOMEN WITH AN ELITE APPLICATOR AND A COOLADVANTAGE APPLICATOR, AN ADVERSE EVENT OF BURN WAS REPORTED BY A PROVIDER. TWO THERMAL EVENTS WERE REPORTED WITH THE ELITE APPLICATOR AND THE PATIENT WAS RETREATED WITH THE COOLADVANTAGE APPLICATOR. ONCE THE COOLADVANTAGE APPLICATOR WAS REMOVED THE PATIENT'S SKIN WAS OBSERVED TO BE BURNED AND PEELING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1380731 | COOLSCULPTING ELITE SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |