MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-18 for ZELTIQ COOFIT APPLICATOR BRZ-AP1-066-000 manufactured by Zeltiq Aesthetics, Inc..
[133574123]
The reported numbness, paresthesia, limited range of motion and ulnar claw were assessed as a serious injury related to the use of the coolsculpting device. The occurrence of sensory and motor changes is a risk inherent to the coolsculpting procedure and is detailed in the coolsculpting user manual. Allergan diligently attempted to gather additional information on the diagnosis and treatment, device information and system logs from the customer, but none has been received from the customer. Treatment of the upper arm with the coolfit applicator is considered an off label use of the device. Treatment of the upper arm was cleared with the cooladvantage petite applicator, which has a treatment profile of -11 degrees celsius and a 35 minute duration, but this was not the applicator type used by the practice on this patient. Zeltiq (now allergan) was initially made aware of the reportable event on (b)(4) 2017, and an initial attempt to submit this mdr was made on 01/03/2018. However, due to transmission issues, this mdr is being re-submitted. Cdrh was notified on 12/21/2018 and has assigned ticket number (b)(4) for this issue.
Patient Sequence No: 1, Text Type: N, H10
[133574124]
On (b)(4) 2017, allergan was informed of an event in which a patient, who was treated to bilateral upper arms with coolsculpting on (b)(6) 2017 using a coolfit applicator, was experiencing difficulty writing with her left hand following treatment and was presenting with ulnar claw. On (b)(6) 2017, upon assessment by a nurse practitioner, the patient presented with decreased ability to extend the fourth digit of the left hand, creating a "claw" appearance, and complained of partial numbness and tingling sensation on the ulnar side of the left hand. Diligent efforts have been made by allergan to obtain device information such as applicator serial number, device system logs, treatment information and updates on the patient's symptoms, but no additional information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007215625-2018-00001 |
| MDR Report Key | 8262032 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2017-07-01 |
| Date Mfgr Received | 2017-07-06 |
| 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 COOFIT APPLICATOR |
| Generic Name | ZELTIQ COOFIT APPLICATOR |
| Product Code | OOK |
| Date Received | 2019-01-18 |
| Catalog Number | BRZ-AP1-066-000 |
| 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 | 2019-01-18 |