MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-24 for CELLFINA SYSTEM CK-1 5036030 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[143052584]
No contact details for the reporter are available, and records show that the complainant has not attempted to reach out to report this event despite the social media monitoring agency providing them with ulthera's contact details. A review of shipping history indicated a single cellfina system was shipped to a customer in (b)(6) whose business name is similar to the office name mentioned in the comment. That office was contacted on 23-apr-2019 and the practice manager stated they would attempt to identify the patient in their records; however, they confirmed on (b)(6) 2019 that they have not treated a patient with the reporter's initials. As information tying the alleged scarring to a specific treatment or treating office is unavailable, device identification and device evaluation cannot be performed. The report contains no allegation of a malfunction and one cannot be confirmed. There is not enough information to confirm whether a device caused or contributed to the event. Should additional information regarding this event become available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143052585]
On (b)(6) 2019, the social media monitoring agency emailed regarding a (b)(6) comment posted on (b)(6) 2019. The comment stated "dont do it!!!! Horrific scarring is occurring! My doctor stopped the procedure at her office!!!! " on (b)(6) 2019, the social media monitoring agency forwarded a screenshot with additional information potentially identifying the doctor's office in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00003 |
| MDR Report Key | 8546618 |
| Report Source | CONSUMER |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JESSICA WARD DYKSTRA |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361457 |
| Manufacturer G1 | ULTHERA, INC., MERZ DEVICE INNOVATION CENTER |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLFINA SYSTEM |
| Generic Name | CELLFINA SYSTEM |
| Product Code | OUP |
| Date Received | 2019-04-24 |
| Model Number | CK-1 |
| Catalog Number | 5036030 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA, INC., MERZ DEVICE INNOVATION CENTER |
| Manufacturer Address | 1840 SOUTH STAPLEY DRIVE SUITE 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-24 |