MAUDE Adverse Event Report: ECTODERMA DBA COSMOFRANCE DERMASCULPT; MICROCANNULA

Lot Number 80804BJ

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 03/29/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, practitioner was injecting a patient using sculptra into the buttock via dermasculpt cannula 25g x 1.5".When cannula was removed, the metal cannula had disconnected from plastic hub.The cannula was left in patient.Patient was transferred to er where metal cannula was surgically removed.On (b)(6) 2019 the practitioner confirmed that the patient was doing well.

• Brand Name: DERMASCULPT
• Type of Device: MICROCANNULA
• Manufacturer (Section D): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave; suite 500; miami FL 33129
• Manufacturer Contact: 2121 sw 3rd ave; suite 500; miami, FL 33129 ; 3055380110
• MDR Report Key: 16375676
• MDR Text Key: 309549892
• Report Number: 3007895168-2022-00007
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Lot Number: 80804BJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2019
• Initial Date FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other