MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2019-01-22 for ZELTIQ COOLMAX APPLICATOR BRZ-AP1-080-000 manufactured by Zeltiq Aesthetics, Inc..
[133763764]
The reported umbilical hernia requiring surgical repair was assessed as a serious injury related to the coolsculpting procedure. The occurrence of hernia, or aggravation of a pre-existing hernia, are risks inherent to the use of the coolsculpting device, and are detailed in the coolsculpting user manual. Device system logs from the initial coolsculpting treatment were retrieved and reviewed. The vacuum pressure was within normal and expected limits, and no device malfunction was identified. Allergan has "dilligently" attempted to gather additional treatment and device information from the second coolsculpting treatment, but no further information was available. Zeltiq (now allergan) was initially made of the reportable event on 03/21/2018, and an initial attempt to submit this mdr was "nade" on 04/24/2018. 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
[133763765]
On 03/21/2018 allergan was made aware that a male patient who received 1 cycle of coolsculpting treatment to the lower abdomen on (b)(6) 2017 using a coolmax applicator and a second coolsculpting treatment at a different treatment provider on an unspecified date, was subsequently diagnosed with symptomatic umbilical hernia requiring surgical repair. The patient denied having pre-existing hernia, prior to receiving coolscultping treatments. On 04/23/2018, device system logs were received from the practice who provided the patient coolscultping treatment on (b)(6) 2017. The system log review was completed on 04/26/2018 and showed that the device performed as designed. The holding vacuum pressure during treatment was within the expected range, and no device malfunction was identified. Allergan has "dilligently" attempted to gather additional clinical information, but no further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00006 |
| MDR Report Key | 8267826 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-21 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2018-03-21 |
| 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 COOLMAX APPLICATOR |
| Generic Name | ZELTIQ COOLMAX APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-22 |
| Model Number | BRZ-AP1-080-000 |
| Catalog Number | BRZ-AP1-080-000 |
| 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 |