COOLSCULPTING SYSTEM
Report
- Report Number
- 3007215625-2023-11887
- Event Type
- Injury
- Date Received
- August 7, 2023
- Date of Event
- January 15, 2018
- Report Date
- August 7, 2023
- Manufacturer
- ALLERGAN (PLEASANTON)
- Product Code
- OOK
- PMA / PMN Number
- K160259
- Removal / Correction Number
- Z-1350-2022/Z-1346-2022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS A HISTORICAL RECORD AND REFLECTS REPORTS THAT WERE RECEIVED BY THE COMPANY PRIOR TO APRIL 2021. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) IS CHARACTERIZED BY A VISIBLY ENLARGED TISSUE VOLUME WITHIN THE TREATMENT AREA, WHICH MAY DEVELOP TWO TO FIVE MONTHS AFTER TREATMENT. SURGICAL INTERVENTION MAY BE REQUIRED. PAH IS NOT RELATED TO ANY COOLSCULPTING DEVICE FAILURE MODE BUT IT IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE BECAUSE IT IS A RISK THAT IS INHERENT TO THE USE CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION.
THIS IS A HISTORICAL RECORD AND REFLECTS REPORTS THAT WERE RECEIVED BY THE COMPANY PRIOR TO APRIL 2021. THIS MDR IS ASSOCIATED WITH A PARALLEL PLATE APPLICATOR, THESE APPLICATORS WERE DISCONTINUED AND RECALLED IN 2022. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) IS CHARACTERIZED BY A VISIBLY ENLARGED TISSUE VOLUME WITHIN THE TREATMENT AREA, WHICH MAY DEVELOP TWO TO FIVE MONTHS AFTER TREATMENT. SURGICAL INTERVENTION MAY BE REQUIRED. PAH IS NOT RELATED TO ANY COOLSCULPTING DEVICE FAILURE MODE BUT IT IS OBSERVED MORE FREQUENTLY WITH THE PARALLEL PLATE APPLICATORS. PAH IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE AS AN INHERENT RISK TO THE USE OF CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING TO UPPER ABDOMEN ON (B)(6) 2017 USING COOLFIT APPLICATOR AND TREATED TO LOWER AND MID ABDOMEN ON (B)(6) 2017 USING COOLMAX APPLICATOR. PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 4 MONTHS AFTER TREATMENT. DIAGNOSED WITH PAH ON (B)(6) 2018 ON EPIGASTRIUM AND PERI UMBILICAL REGION. PAH DESCRIBED AS TISSUE CHARACTERISTICS WERE DESCRIBED AS HARDNESS/ FIRMNESS.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING TO UPPER ABDOMEN ON (B)(6) 2017 USING COOLFIT APPLICATOR AND TREATED TO LOWER AND MID ABDOMEN ON (B)(6) 2017 USING COOLMAX APPLICATOR. PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 4 MONTHS AFTER TREATMENT. DIAGNOSED WITH PAH ON (B)(6) 2018 ON EPIGASTRIUM AND PERI UMBILICAL REGION. PAH DESCRIBED AS TISSUE CHARACTERISTICS WERE DESCRIBED AS HARDNESS/ FIRMNESS.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING TO UPPER ABDOMEN ON (B)(6) 2017 USING COOLFIT APPLICATOR AND TREATED TO LOWER AND MID ABDOMEN ON (B)(6) 2017 USING COOLMAX APPLICATOR. PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 4 MONTHS AFTER TREATMENT. DIAGNOSED WITH PAH ON (B)(6) 2018 ON EPIGASTRIUM AND PERI UMBILICAL REGION. PAH DESCRIBED AS TISSUE CHARACTERISTICS WERE DESCRIBED AS HARDNESS/ FIRMNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795968 | COOLSCULPTING SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN (PLEASANTON) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention | (B)(6) |