MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-02-19 for COOLSCULPTING APPLICATOR manufactured by Zeltiq Aesthetics, Inc..
[136588634]
The alleged hernia requiring surgery was assessed as a serious injury related to the use of the coolsculpting device. Even though the allegation remains unsubstantiated at this point, out of abundance of caution this case is being assessed and addressed conservatively as a reportable event, even with the limited information available. Diligent efforts have been made to obtain additional information on the event, treatment provider, treatment details and device used, however no additional information has been received from the reporter to date. Additional information on this report is being sought. The coolsculpting system has been studied exclusively in healthy adult volunteers. A hernia is not a contraindication of coolsculpting, however, in the coolsculpting user manual, listed under warnings, it states that special considerations should be taken with patients who have hernia in or adjacent to the treatment site. Coolsculpting uses vacuum and non-vacuum applicators to complete coolsculpting procedures. The vacuum applicators draw tissue into the applicator cup during the treatment. Using a vacuum pressure applicator on a pre-existing hernia or pre-existing structurally weak area may cause further complications. The thinning of the fat layer alone may also cause an occult hernia to become more evident in certain patients. Allergan advises physicians to carefully examine the patient for evidence of pre-existing hernias prior to use of the device.
Patient Sequence No: 1, Text Type: N, H10
[136588635]
On 01/24/2019, allergan was made aware of an online post where the reporter stated she had received coolsculpting treatment and ended up needing hernia surgery on the treated area four months post treatment. Diligent efforts have been made to obtain additional information on the event, treatment provider, treatment details and device used, however no additional information has been received from the reporter to date. Even though the allegation remains unsubstantiated at this point, out of abundance of caution, this case is being assessed and addressed conservatively as a reportable event, even with the limited information available. Additional information on this report is being sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00012 |
| MDR Report Key | 8352464 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-02-19 |
| 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 | COOLSCULPTING APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-02-19 |
| 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 | 2019-02-19 |