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..
[133756952]
The reported recurrence of a previously repaired umbilical hernia, for which surgical intervention was performed to prevent further complications, 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. Allergan has "dilligently" attempted to gather additional information such as treatment and device information, but the coolsculpting treatment provider was no longer in business. No further information was available. Zeltiq (now allergan) was initially made of the reportable event on 02/02/2018, and an initial attempt to submit this mdr was "nade" on 02/28/2018. 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
[133756953]
On 02/02/2018 allergan was made aware that a male patient with a history of umbilical hernia repair in 2011 received coolsculpting treatment to the upper abdomen on (b)(6) 2017, and subsequently experienced umbilical re-herniation approximately 15 days after coolsculpting treatment. The patient underwent a laparoscopic recurrent hernia repair with mesh on (b)(6) 2017. Allergan has "dilligently" attempted to gather additional information such as treatment and device information, but the coolsculpting treatment provider was no longer in business. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00004 |
| MDR Report Key | 8267750 |
| Report Source | CONSUMER |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-21 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2018-02-02 |
| 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 |