MAUDE Adverse Event Report: MERZ AESTHETICS, INC. RADIESSE DERMAL FILLER; INJECTABLE IMPLANT

Catalog Number 8071M0K1

Device Problem Malposition of Device (2616)

Patient Problems Hematoma (1884); Numbness (2415)

Event Date 04/03/2015

Event Type  Injury  

Event Description

Injector reported a (b)(6) female patient was injected with two 1.5cc syringes of radiesse to the cheeks and nasolabial folds.Injector stated she only put "a little" in the cheeks, more medially.Immediately post injection, the patient experienced numbness in the left cheek.On the way home, the patient's left eye began hurting.Today, (b)(6) 2015, she has a bruise on the left upper cheek.The numbness, which is closer to the nose, is starting to wear off.When she moves her left eye, it feels sore.She has not experienced change in vision.Injector said she considers the numbness more related to a nerve issue.On (b)(6) 2015, injector consulted with a (b)(4) nurse and informed the (b)(4) nurse that she attributed the numbness to the lidocaine that was mixed into the radiesse and that the patient developed a significant hematoma beneath the left eye.

Manufacturer Narrative

On (b)(6) 2015, during follow up call, injector reported patient is doing well.She had a small hematoma and purulent drainage so they did consider patient had an infection and treated her with a course of keflex, which patient completed.The infection resolved.The swelling and bruising are gone.Cultures were not done.On follow up, patient still had numbness but it had receded from the cheek down to the nose and mid-lip areas.The device history records for the reported lot were reviewed.All required incoming, in process, and final release testing specifications for this lot were met prior to release.

• Brand Name: RADIESSE DERMAL FILLER
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ AESTHETICS, INC.; franksville WI
• Manufacturer Contact: tammy watson ; 4133 courtney rd., suite 10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4685506
• MDR Text Key: 5642990
• Report Number: 2135225-2015-00023
• 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: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 8071M0K1
• Device Lot Number: 100078327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Treatment: 0.3CC OF 2%LIDOCAINE; BOTOX, 24 UNITS TO GLABELLA
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR