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 Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, foreign body reaction (foreign body reaction), 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 mdr is related to 3013840437-2021-00196 referring to the same patient.This spontaneous report was received from a us health care professional and concerns a patient.The patient was injected with radiesse®, a month prior to this report, in 2021.Radiesse® was hyper-diluted.The area reportedly looked great after the injection.In 2021, after the treatment with radiesse®, the patient experienced a calcification proximal to where radiesse® was injected.There was a calcified mass about 3mm x 10mm in size, sharp and hard when palpated.Three to four days prior to report, the injector used hylenex, however, it did not do anything.Due to provided information, the outcome of the events was considered as not resolved.Follow-up information was received on 25-sep-2021: this case was upgraded to serious.The event term calcification/calcified mass was amended to calcification/calcified mass/ large calcified mass was radiesse, and it was recoded from injection site calcification to product distribution issue.The event foreign body reaction was added.The patients initials, gender, date of birth and age were provided.The patient was a (b)(6)female patient.It was confirmed that she was injected with radiesse, into the n/c fold (as reported).On (b)(6) 2021, the patient had a soft tissue lower lip excision and a biopsy.On (b)(6) 2021, it confirmed that the large calcified mass was radiesse.The diagnosis was calcium hydroxyapatite dermal filler with a foreign body reaction.Microscopic description stated that the sections consisted of many pieces of skeletal muscle within which there were many faintly refractile spherical foreign body particles that were mauve-green in colour, surrounded by epithelioid histocytes and foreign-body type giant cells.Some of these particles were within the giant cells.Gross description stated that it was received in formalin and was a 1.5 x 1.0 x 0.2 cm aggregate of friable tan tissue fragments and a white soft inorganic substance.Due to loss of elastic tension and formalin shrinkage, th emeasurements in the laboratory description were possibly less than those taken at the time of surgical removal.The clinical impression was a foreign body/filler extravasation.The outcome of the events calcification/calcified mass/ large calcified mass was radiesse and sharp and hard to palpate, remained unchanged.Due to the provided information, the outcome of the event foreign body reaction was considered as not resolved.

• 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: 12577514
• MDR Text Key: 274774067
• Report Number: 3013840437-2021-00195
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2021
• 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: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR