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

Lot Number 1001130305

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event possible occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage. The device history record of radiesse (+) injectable implant 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 patient. The patient was injected with radiesse(+), into the nasolabial folds, cheeks and tear trough region (off label use of device). After the treatment with radiesse(+), the patient experienced significant swelling and pain when injected into the tear trough. The outcome of the events was unknown. Follow-up information was received on 14-apr-2022: this case was upgraded to serious. The event possible occlusion was added. The events swelling and pain were deleted, they were considered to be symptoms of the reported possible occlusion. After the treatment with radiesse(+), the patient experienced significant swelling in the tear trough area and severe pain. It was further described as a possible occlusion. The outcome of the event was unknown.

• 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: 14167410
• MDR Text Key: 289750104
• Report Number: 3013840437-2022-00058
• 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

• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 1001130305
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/21/2022 Patient Sequence Number: 1

Treatment

CONCOMITANT DRUG NOT AVAILABLE