COOLSCULPTING® SYSTEM
Report
- Report Number
- 3007215625-2023-00599
- Event Type
- Injury
- Date Received
- May 8, 2023
- Date of Event
- July 15, 2022
- Report Date
- May 8, 2023
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K160259
- Removal / Correction Number
- Z-1349-2022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: D4, D1. H11-: CORRECTED DATA: H9.
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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED. ZELTIQ INITIATED A VOLUNTARY DISCONTINUATION AND RECALL OF PARALLEL PLATE APPLICATORS FOR THE COOLSCULPTING® SYSTEM DUE TO THE OBSERVANCE OF AN INCREASED RATE OF PARADOXICAL HYPERPLASIA (PH) ASSOCIATED WITH THESE APPLICATORS DURING A RECENT ANALYSIS OF DATA FROM THE 2019-2021 TIMEFRAME. THESE APPLICATORS ARE SOLD UNDER THE BRAND NAMES COOLCORE, COOLCURVE, COOLCURVE+, COOLMAX AND COOLFIT.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE UNDER THE CHIN, UPPER FLANK (CHEST), AND INFRA-SCAPULAR AREAS ON (B)(6) 2022 USING COOLMINI AND LEGACY COOLCURVE PLUS AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AFTER TREATMENT. DIAGNOSIS BY NURSE WITHIN CEF ON (B)(6) 2023.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE UNDER THE CHIN, UPPER FLANK (CHEST), AND INFRA-SCAPULAR AREAS ON (B)(6) 2022 USING COOLMINI AND LEGACY COOLCURVE PLUS AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AFTER TREATMENT. DIAGNOSIS BY NURSE WITHIN CEF ON (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638963 | COOLSCULPTING® SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Required Intervention |