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 2019-01-18 for ZELTIQ COOLADVANTAGE APPLICATOR BRZ-AP2-160-000 manufactured by Zeltiq Aesthetics, Inc..
[133721609]
The reported tissue necrosis, which caused patient hospitalization and necessitated medical intervention to avoid serious complications, was assessed as a serious injury with a possible, although not established, relationship to the coolsculpting procedure. Diligent efforts have been made by allergan to gather more information on the device information and system logs, but no additional information has been received to date. Zeltiq (now allergan) was initially made aware of the reportable event on 12/19/2017, and an initial attempt to submit this mdr was made on 01/31/2018. However, due to transmission issues, this mdr is being re-submitted. Cdrh was notified on (b)(4) 2018 and has assigned ticket number (b)(4) for this issue.
Patient Sequence No: 1, Text Type: N, H10
[133721610]
On (b)(6) 2017, allergan received report from a treatment provider that a patient received 6 coolsculpting treatments to the upper and lower abdomen and bilateral flanks on (b)(6) 2017 and had presented with redness, warmth and pain on the treated areas 4 days after treatment. The patient was prescribed clindamycin 300mg tid for 10 days, and bactroban topical ointment to be applied to the affected area every 8 hours for 3-5 days. On (b)(6) 2017, the patient was subsequently hospitalized for a fever of 103 degrees. He remained in the hospital for five days and was treated with iv antibiotics, pain medication, and steroids. A biopsy was performed and showed non-bacterial tissue necrosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00003 |
| MDR Report Key | 8262725 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2019-01-18 |
| 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 APPLICATOR |
| Generic Name | ZELTIQ COOLADVANTAGE APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-18 |
| Model Number | BRZ-AP2-160-000 |
| Catalog Number | BRZ-AP2-160-000 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-01-18 |