MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-01-17 for ZELTIQ APPLICATOR manufactured by Zeltiq Aesthetics, Inc..
[133548029]
The reported umbilical hernia was assessed as a serious injury related to the use of the coolsculpting device. Hernia generally requires surgical intervention to correct and prevent further complications. The occurrence of hernia is a risk inherent to the coolsculpting procedure and is detailed in the coolsculpting user manual. Allergan diligently attempted to gather additional information on the diagnosis and treatment, device information and system logs from the customer, but none has been received from the customer. Zeltiq (now allergan) was initially made aware of the reportable event on (b)(6) 2017, and an initial attempt to submit this mdr was made on (b)(4) 2017. However, due to the incorrect method of submission recently identified and being rectified by the organization, and for which fda's guidance was sought in december 2018 under (b)(4), this mdr is being re-submitted on 01/17/2019.
Patient Sequence No: 1, Text Type: N, H10
[133548030]
On 11/20/2017 allergan received report from a practice that an employee received 2 cycles of coolsculpting treatment to the upper and lower abdomen in 2015 and had subsequently developed an umbilical hernia on (b)(6) 2017, allergan received information that the patient underwent surgical repair for the hernia on (b)(6) 2016. The patient indicated she previously had a hernia to the groin, prior to receiving coolsculpting treatments. Diligent efforts were made by allergan to obtain additional information on the diagnosis, related treatment, and system logs, but none has been received from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2017-00010 |
| MDR Report Key | 8259100 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2019-01-17 |
| 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 | 2019-01-17 |
| 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 | 2019-01-17 |