MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-22 for ZELTIQ APPLICATOR manufactured by Zeltiq Aesthetics, Inc..
[133794514]
The reported second and third degree burns were assessed as a serious injury possibly related to the use of the coolsculpting device. Although the coolsculpting applicators do not have the capability of simultaneous applicator placement as demonstrated in the photos, and the well-defined circular shape of the burn wounds were not consistent with the configuration of coolsculpting applicators and gel trap, the temporal relationship between the occurence of the burns and the coolsculpting treatment suggest the coolsculpting treatment may have contributed to the injury. Allergan has diligently made multiple attempts to gather additional information on the treatment and device information, but no further information was received. The coolsculpting system operates at temperature that can freeze tissues. The system monitors tissue during cooling and employs multiple safety features to minimize the risk of damage to tissue. In spite of these measures, on rare occasions, skin freeze can still occur, as in this case.
Patient Sequence No: 1, Text Type: N, H10
[133794515]
On 03/30/"2017", allergan was made aware that a female patient had sustained second and third degree burns to the abdomen following coolsculpting treatment in (b)(6) 2017. Ice packs secured with bandages were applied on the treatment site for an unspecified duration. Allergan received photos depicting four well-defined circular burn injuries with the same degree of severity, suggesting that the patient was likely treated simultaneously with four applicators. However, the coolsculpting applicators do not have the capability of simultaneous applicator placement as demonstrated in the photos. Additionally there have been no previous complaints involving an injury that has a well-defined circular shape as demonstrated in the photos, as injuries related to coolsculpting applicators typically present in the shape of the applicator and/or the gel trap, neither of which has a round shape. Lastly, the patient alleged that ice was placed to the treatment site and wrapped with a bandage following treatment. While the length of time the ice was placed is not available, it is likely that this further exacerbated the severity of the patient's injuries. The patient also reported undergoing numerous unspecified procedures to correct the injuries and needing lifelong medical treatment, monitoring, and medication as a result of the burns. Allergan has diligently made multiple attempts to gather additional information on the reported event, treatment and device information, but no further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00008 |
| MDR Report Key | 8268908 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2017-04-01 |
| Date Mfgr Received | 2018-03-30 |
| 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 | 0 |
| 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 |