Coolsculpting System · Dermal cooling pack/vacuum/massager
Allergan Pleasanton · Adverse Event Without Identified Device or Use Problem
- Manufacturer contact state
- CA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Pleasanton
- Manufacturer contact address 1
- 2525 Dupont Drive
- Manufacturer contact pcity
- +1(847)9
- Event type
- Injury
- Report number
- 3007215625-2026-00500
- Product problem flag
- N
- Date received
- 20260930
- PMA pmn number
- K160259
- Date of event
- 20260825
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 92612
- Reporter occupation code
- PHYSICIAN
- Manufacturer contact plocal
- +1(847)936-6324
- Noe summarized
- 1
- Manufacturer contact l name
- Ingram
- Manufacturer g1 postal code
- 94588
- Manufacturer g1 state
- CA
- Reporter country code
- CA
- Date added
- 20260930
- Manufacturer contact f name
- Terry
- Previous use code
- R
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- Y
- Summary report flag
- N
- Date report
- 20260929
- Initial report to FDA
- Yes
- Manufacturer g1 country
- US
- Manufacturer contact city
- Irvine
- MDR report key
- 50941443
- Date manufacturer received
- 20260902
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 94588
- Manufacturer g1 name
- Allergan (Pleasanton)
- Adverse event flag
- Y
- Single use flag
- N
- Manufacturer g1 address 1
- 4410 Rosewood Dr
- Manufacturer contact postal code
- 92612
- Type of report
- Initial submission
- Source type
- Foreign, Health Professional
- Device
- Device sequence number
- 87402
- Date received
- 20260930
- Brand name
- Coolsculpting System
- Generic name
- Dermal cooling pack/vacuum/massager
- Manufacturer d name
- Allergan Pleasanton
- Manufacturer d address 1
- 4410 Rosewood Dr
- Manufacturer d city
- Pleasanton
- Manufacturer d state
- CA
- Manufacturer d zip code
- 94588
- Manufacturer d country
- US
- Manufacturer d postal code
- 94588
- Device operator
- HEALTH PROFESSIONAL
- Catalog number
- SA16789
- Device report product code
- OOK
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- Harmonized identifiers (openFDA)
- Device name
- Dermal Cooling Pack/Vacuum/Massager
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4340
- Device class
- 2
- Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient
- Patient sequence number
- 1
- Date received
- 20260930
- Patient age
- 59 YR
- Patient sex
- Female
- Patient race
- White
- Sequence number outcome
- Required Intervention
- Patient problems
- Hyperplasia