MAUDE MDR 50941443
- MDR report key
- 50941443
- Report number
- 3007215625-2026-00500
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-08-25
- Date received
- 2026-09-30
- Adverse event
- 1
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 1
- Initial report to FDA
- 1
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 87402 | Coolsculpting System | Dermal cooling pack/vacuum/massager | Allergan Pleasanton | OOK | | SA16789 | | | | | N | |
| 418196 | Coolsculpting System | Dermal cooling pack/vacuum/massager | Allergan Pleasanton | OOK | | SA16789 | | | | | N | |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-09-30 | 0 | R |
Event Narratives#
No narrative records found.