MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-22 for UPPER MODULE, COM1 201665 manufactured by .
[139664628]
Allergan has exercised all due diligence to gather additional information from the social media poster through multiple phone calls and emails, but to no avail. The reporter, through a message relayed by his secretary, has declined to communicate with allergan regarding the incident or respond to any of its requests for additional information. Although the allegation remains unsubstantiated, the event will be assessed conservatively as serious and related to the device out of an abundance of caution. Trauma is one of the factors leading to fat embolism. Cryolipolysis, the mechanism by which coolsculpting reduces fat, involves trauma to adipose tissue through a cooling process. No previous occurrence of fat embolism has been reported to zeltiq. At this time, there are no publications or study data available to confirm that coolsculpting can contribute to fat embolism. The occurrence of such an event is highly unlikely, but not impossible.
Patient Sequence No: 1, Text Type: N, H10
[139664629]
On (b)(4) 2019 allergan was made aware of an allegation of fat embolism leading to death, posted on a coolsculpting treatment provider's website. The post states, "my neighbor died from it by fat embolism. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2019-00012 |
| MDR Report Key | 8445974 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER CLETO |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9256214130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPPER MODULE, COM1 |
| Generic Name | DERMAL COOLING PACK/VACUUM/MASSAGER |
| Product Code | OOK |
| Date Received | 2019-03-22 |
| Catalog Number | 201665 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-22 |