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 2019-01-22 for ZELTIQ APPLICATOR manufactured by Zeltiq Aesthetics, Inc..
[133837018]
The reported tender, warm, erupting subcutaneous nodules that were diagnosed as fat necrosis were assessed as a significant medical event. While there was no immediate threat of an irreversible damage to a body structure or permanent loss of bodily function, as the physician stated the nodules will resolve on their own over time, the needle aspiration/drainage performed by the physician was necessary to prevent further enlargement and eruption of the nodules. Zeltiq (now allergan) was initially made of the reportable event on (b)(6) 2018, and an initial attempt to submit this mdr was made on (b)(6) 2018. However due to transmission issues, this mdr is being re-submitted. (b)(6) was notified on (b)(6) 2018 and has assigned ticket number (b)(4) for this issue.
Patient Sequence No: 1, Text Type: N, H10
[133837019]
On (b)(6) 2018 allergan received report that a female patient received coolsculpting treatment to the abdomen on (b)(6) 2016 and subsequently developed palpable nodules under her skin, after treatment. The physician palpated multiple small nodules deeper in the subcutaneous fat on both sides of the belly button. At one point, one of the nodules became visibly raised, erupted, and has formed a scar. By (b)(6) 2017, the nodules had turned hard, red, and very tender and hot to touch. In (b)(6) 2018, one of the nodules had drained a pinkish odorless fluid. On (b)(6) 2018, allergan was made aware that the patient consulted a dermatologist who provided a diagnosis of fat necrosis and performed needle aspiration to drain fat/oil from some of the nodules. Allergan has diligently attempted to gather additional information on the device used, but no further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00007 |
| MDR Report Key | 8268210 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-03-21 |
| 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. Other | 2019-01-22 |