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

Catalog Number 8063M11K1

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/21/2022

Event Type  Injury  

Event Description

This mdr is related to mdr 3013840437-2022-00028 referring to the same patient. This spontaneous report was received form a german physician and concerns a female patient. She was injected with a total of 1. 5 ml of radiesse(+), for an augmentation of the nasolabial folds, on (b)(6) 2022. She was injected with 0. 75 ml on each side. The patients medical history and concomitant medication were reported as none. On (b)(6) 2022, after the radiesse(+) injection, the patient experienced an ischemia due to a compression of the supplying vessel. On (b)(6) 2022, the patient reported this to her treating physician, who notified the reporter, on the same day, in the evening (ambiguously reported as (b)(6) 2022). As corrective treatment, the patient received acetylsalicylic acid, warmth and 300 units of hyaluronidase. The outcome of the events was reported as resolving.

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event ischemia due to a compression of the supplying vessel (pt: vascular compression), 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.

• 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: 13636003
• MDR Text Key: 290810746
• Report Number: 3013840437-2022-00033
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 8063M11K1
• Device Lot Number: A00039890
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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: 03/01/2022 Patient Sequence Number: 1

Treatment

CONCOMITANT DRUG NOT AVAILABLE