MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-22 for ZELTIQ COOLSMOOTH PRO APPLICATOR BRZ-AP1-091-001 manufactured by Zeltiq Aesthetics, Inc..
[133830395]
The reported hospitalization and diagnoses of deep vein thrombosis (dvt) and lung embolism (pulmonary embolism) were assessed as serious injury, as they require medical intervention to prevent serious complications. While there is no known mechanism in which coolsculpting would directly cause dvt and subsequent pulmonary embolism, without additional information demonstrating the sequence of events and patient specific information including medical conditions and medications, the contribution of the device to the adverse event could not be ruled out. Allergan has diligently made multiple attempts to gather clinical, treatment and device information, but no further information was received. Zeltiq (now allergan) was initially made aware of the reportable event on (b)(4) 2018, and an initial attempt to submit this mdr was made. However, due to transmission issues, this mdr is being re-submitted. Cdrh was notified on 12/21/2018 and has assigned ticket number (b)(4) for this issue.
Patient Sequence No: 1, Text Type: N, H10
[133830396]
On (b)(4) 2018 allergan was made aware that a patient who had received coolsculpting treatments to the thighs and upper legs, 2 treatments using coolsmooth pro and four treatments with cooladvantage petite, experienced pain on the lower leg and calves sometime after the treatment. The patient was hospitalized and diagnosed with deep vein thrombosis (dvt) and lung embolism. The treat date and date of onset of symptoms were not provided by the reporter. Allergan has diligently made multiple attempts to gather clinical, treatment and device information, but no further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00010 |
| MDR Report Key | 8269425 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2019-01-22 |
| 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 |
| Manufacturer G1 | ZELTIQ AESTHETICS, INC. |
| Manufacturer Street | 4410 ROSEWOOD DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZELTIQ COOLSMOOTH PRO APPLICATOR |
| Generic Name | ZELTIQ COOLSMOOTH PRO APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-22 |
| Model Number | BRZ-AP1-091-001 |
| Catalog Number | BRZ-AP1-091-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZELTIQ AESTHETICS, INC. |
| Manufacturer Address | 4410 ROSEWOOD DRIVE PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-01-22 |