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 APPLICATOR manufactured by Zeltiq Aesthetics, Inc..
[133836590]
The reported symptoms/conditions were assessed as a serious injury related to the use of the coolsculpting device. The coolsculpting user manual lists cryoglobulinemia as one of the absolute contraindications for patients undergoing localized skin cooling treatments. Neither the treatment provider nor the patient was unaware that the patient had cryoglobulinemia prior to receiving coolsculpting treatments. Diligent efforts have been made by allergan to gather more information on the diagnoses, treatments, device information, system logs and updates on patient's symptoms, but no additional information has been received to date. 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) 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
[133836591]
On (b)(6) 2017, allergan received report from a treatment provider that a patient received coolsculpting treatment to the abdomen on an unspecified date and had subsequently developed a problem with her left brachialis plexus similar to parsonage-turner syndrome and morbus schamberg, a leucocytoclastic vasculitis (diagnosed via biopsy) in her legs 2 months after treatment. The physician stated that prior to receiving coolsculpting treatment, neither he nor the patient was unaware that the patient had cryoglobulinemia. Diligent efforts have been made by allergan to gather more information on the diagnoses, treatments, device information, system logs and updates on patient's symptoms, but no additional information has been received to date. The coolsculpting user manual lists cryoglobulinemia as one of the absolute contraindications for patients undergoing localized skin cooling treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00002 |
| MDR Report Key | 8262538 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-12-05 |
| 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 |
| Generic Name | ZELTIQ APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-18 |
| 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 | 2019-01-18 |