MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-22 for ZELTIQ APPLICATOR manufactured by Zeltiq Aesthetics, Inc..
[133826677]
The alleged third degree burn reportedly sustained by the patient after receiving coolsculpting treatment was assessed as a serious injury related to the use of the coolsculpting device. Third degree burns require medical intervention to prevent serious complications. Allergan has been diligently making attempts to gather additional clinical, treatment and device information from the patient's attorney, as the patient stated she is legally represented by a lawyer, but no further information has been received to date. A supplemental report will be submitted once additional information is received by allergan. Zeltiq (now allergan) was initially made aware of the reportable event on 10/05/2018, 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
[133826678]
On 10/05/2018, allergan received report that a patient received coolsculpting treatment on (b)(6) 2018 and subsequently sustained a third-degree burn on the treated area. Allergan has been diligently making attempts to gather additional clinical, treatment and device information from the patient's attorney, as the patient stated she is legally represented by a lawyer, but no further information has been received to date. A supplemental report will be submitted once additional information is received by allergan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00011 |
| MDR Report Key | 8269508 |
| Report Source | CONSUMER |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-10-05 |
| 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 |
| Generic Name | ZELTIQ APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-22 |
| 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. Required No Informationntervention | 2019-01-22 |