MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC RADIESSE DERMAL FILLER; INJECTABLE IMPLANT

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Erythema (1840); Occlusion (1984); Swelling (2091)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient's injection site has recovered.There is some minor redness that could be reduced with laser treatments.The device history record for the injected radiesse lot was not reviewed as the lot number was unknown.Device not returned to the manufacturer.

Event Description

A female patient was injected with 0.85cc of radiesse to the nose (nasal tip-0.1ml, columella-0.3ml, root-0.45 ml) on (b)(6) 2015.The patient experienced severe swelling after the injection compared with previous treatment.On (b)(6) 2015, the patient was started on antibiotics three times daily prophylactically by the injector.On (b)(6) 2015, the patient was given gentamycin and cephamycin intravenously and orally, along with warm compresses to the area.On (b)(6) 2015, the patient went to the (b)(6) for wound treatment.The "chief of hospital diagnosis" suspected patient had cellulitis and patient was hospitalized.On (b)(6) 2015, the patient began having hyperbaric oxygen therapy (hbot) twice daily.The patient had a total of 16 hbot through (b)(6) 2015, when she was discharged.(b)(6) 2015, the patient's nose tip still has redness & the patient keeps doing hbot.On (b)(6) 2015, the patient did not go back to the hospital for a final examination but visited another physician with her photographs.The physician considered that the diagnosis should be vascular occlusion, not cellulitis.The patient's injection site has recovered.There is some minor redness that could be reduced with laser treatments.

• Brand Name: RADIESSE DERMAL FILLER
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 6501 six forks rd; raleigh NC 27615
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney rd; franksville WI 53126
• Manufacturer Contact: ann metz ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 5097304
• MDR Text Key: 26550478
• Report Number: 2135225-2015-00062
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention