MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. RADIESSE (+) INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, stroke (pt: cerebrovascular accident), was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.

Event Description

This spontaneous report was received from a us nurse and concerns a (b)(6)-year-old female patient.She was injected with 1 syringe of radiesse(+)®, into the jawline.Two weeks after the treatment with radiesse(+)®, the patient experienced a stroke.As reported, the other day, the patient came in and reported it.The patient did not make a correlation with the filler and the stroke, but the reporter was curious about it.The outcome of the event was unknown.Follow-up information was received on 27-apr-2021: it was confirmed that the patient was injected with radiesse(+)®, on (b)(6) 2021.On (b)(6) 2021, 1 day after the treatment with radiesse(+)®, the patient experienced a stroke.The outcome of the event was left unchanged.

• Brand Name: RADIESSE (+) INJECTABLE IMPLANT
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 11778546
• MDR Text Key: 264490387
• Report Number: 3013840437-2021-00116
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/05/2021
• 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): Required Intervention
• Patient Age: 62 YR