MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-16 for ZELTIQ COOLADVANTAGE PLUS APPLICATOR BRZ-AP2-180-000 manufactured by Zeltiq Aesthetics, Inc..
[133314027]
The reported "black necrotic tissue" with blistering was assessed as a serious injury related to the use of the coolsculpting device and requiring medical intervention to prevent irreversible damage to a body structure and/or body function. Burns are risks inherent to the use of the coolsculpting device, and are detailed in the coolsculpting user manual. The device system logs from the treatment were analyzed, and it was found that an alert by the system "freeze event (z409-383)" was detected by the software, to alert the user. The coolsculpting user manual states as caution that when a thermal event (z409-yyy) is detected, the applicator and gel pad should be removed, and the area should not be retreated for 24 hours, to prevent the occurrence of burns on the area. The treatment provider re-treated the same area right away, despite the freeze event. The device functioned as designed by sending the alarm. 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)(6) 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 (b)(6) 2018 under (b)(4), this mdr is being re-submitted on 01/16/2019.
Patient Sequence No: 1, Text Type: N, H10
[133314028]
On (b)(6) 2017, allergan received report from a practice that a patient received coolsculpting treatment to the left flank on (b)(6) 2017 using cooladvantage plus, and had subsequently presented with "black" necrotic tissue after being re-treated on the same area on the same day, despite the occurrence of a thermal event (z409-383). The site was assessed as a burn and was treated with elta silver gel, aloe, and second skin dressing, and the patient was started on prophylactic doxycycline 100 mg bid po for 14 days. There was blistering at the site, which was lanced, and surrounding bruising that was dressed with auriderm dressing. The patient reported associated pain, which was treated with ibuprofen, vicodin, and a tens units. As of (b)(6) 2018, the patient's burn is healing and the pain is almost gone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2017-00005 |
| MDR Report Key | 8255314 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-16 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2019-01-16 |
| 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 COOLADVANTAGE PLUS APPLICATOR |
| Generic Name | ZELTIQ COOLADVANTAGE PLUS APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-16 |
| Catalog Number | BRZ-AP2-180-000 |
| 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 | 2019-01-16 |