MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-26 for THE CELLFINA SYSTEM CK1-EU CK1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[103693496]
The device has been requested back for evaluation and follow ups regarding the treatment have been made on (b)(6) 2018, and (b)(6) 2018. When additional information regarding this event becomes available, a supplemental medwatch will be filed. This event occurred in (b)(6), although the medwatch form 3500a abbreviates the country as "(b)(6)". (b)(6) is typically the two-letter abbreviation for (b)(6), while at is typically the two-letter abbreviation for (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[103693497]
On (b)(6) 2018, the merz affiliate in (b)(4) was made aware of a product problem that occurred in (b)(6). It was reported that the blade from a cellfina disposable kit broke during a treatment requiring retrieval. No additional local anaesthetic was administered nor were sutures required to close the retrieval point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00001 |
| MDR Report Key | 7370565 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-26 |
| Date of Report | 2018-02-09 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2018-03-26 |
| 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. 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 | THE CELLFINA SYSTEM |
| Generic Name | CELLFINA SYSTEM |
| Product Code | OUP |
| Date Received | 2018-03-26 |
| Returned To Mfg | 2018-03-13 |
| Model Number | CK1-EU |
| Catalog Number | CK1 |
| Lot Number | 46013651 |
| Device Expiration Date | 2018-05-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2018-03-26 |