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 COOLMINI APPLICATOR BRZ-AP2-020-000 manufactured by Zeltiq Aesthetics, Inc..
[133829910]
Although the reported symptoms of inability of the right eye to blink, numbness of the right side of the chin, lips and gums, and face resolved two weeks following onset without permanent or long-term sequelae, bell's palsy was assessed as a significant medical event. Due to the nature and temporal relationship of the onset of symptoms and the coolsculpting procedure, a causal or contributory relationship can neither be discounted nor established. The provider did not report any errors or malfunction of the device during treatment. Allergan has diligently made multiple attempts to gather additional device information, but no further information was received. Zeltiq (now allergan) was initially made aware 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. Cdrh was notified on (b)(6) 2018 and has assigned ticket number (b)(4) for this issue.
Patient Sequence No: 1, Text Type: N, H10
[133829911]
On 04/11/2018, allergan was made aware that a female patient who received 2 cycles of coolsculpting treatment on both sides of the submental area on (b)(6) 2018 using coolmini applicators, started experiencing irritation and inability of the right eye to blink, numbness of the right side of the chin, lips and gums, and face on (b)(6) 2018. On the same day, the patient was seen by the treatment provider who suspected the patient had developed bell's palsy and prescribed prednisone. On (b)(6) 2018 the patient's primary care physician confirmed that the patient had bell's palsy. On (b)(6) 2018, allergan received confirmation from the treatment provider that all the reported symptoms have completely resolved two weeks following onset. Allergan has diligently made multiple attempts to gather device information, but no further information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00009 |
| MDR Report Key | 8268934 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-04-11 |
| 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 |
| Brand Name | ZELTIQ COOLMINI APPLICATOR |
| Generic Name | ZELTIQ COOLMINI APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-22 |
| Model Number | BRZ-AP2-020-000 |
| Catalog Number | BRZ-AP2-020-000 |
| 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. Other | 2019-01-22 |