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

Catalog Number 8063M4K1

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

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, accidental intra arterial injection, was deemed to meet the serious injury criteria of required intervention to preclude permanent impairment of a body function or permanent damage of a body structure.The device history record for radiesse+ lot 100124937 was reviewed.No non-conformances were noted that would contribute to this event.

Event Description

This spontaneous report was received from a (b)(6) physician and concerns a (b)(6)-year-old male patient.He was injected with radiesse(+)® into the laugh lines, from nose to lip, on (b)(6) 2020.The patient was treated by a non-medical professional (a clinic owner), not deep (as reported) and using a needle included in box.Batch number was reported as 100124937 (expiry date 09/2021).A lot search in the global safety database was conducted.The patient has been injected with fillers, by the same injector, many times in the past with no complications.Further patient's medical history and concomitant medications were reported as none.In (b)(6) 2020, within 2 days after the treatment with radiesse(+)®, the patient experienced pain and visible redness, on the right side.On (b)(6) 2020, the patient was evaluated by the physician, who thought it was an infection.Corrective treatment included warm compresses, acetyl salicylic acid, 81mg once a day, cloxacillin, 500 mg four times a day.The patient was not hospitalized.On (b)(6) 2020, the physician reported that the patient was much better and felt there had been slight improvement.He had no pain, the area of erythema had not increased and, as reported, the area did not feel firm and thickened as the day before.He was getting more little white pustules and had a vague tingling sensation in the area.He was applying a warm compress and taking a baby aspirin daily to improve circulation as well as the antibiotic cloxacillin prescribed by the physician.The diagnosis was a presumed accidental arterial injection.On (b)(6) 2020, the physician reported that the patient had almost completely recovered.The outcome of the event pain was reported as resolved, in (b)(6) 2020.Due to the provided information, the outcome of the event firm and thickened was considered as resolved in (b)(6) 2020, and of all other events as resolving.In the opinion of the reporter, the events were of moderate intensity, not life-threatening, unknown if permanent, and related to radiesse(+)® but not to incorporated local anaesthetic.Follow-up information was received on 24-jul-2020: the case was upgraded to serious.The events pain and visible redness were deleted.The physician reported that he did not believe that the patient was going to had permanent damage.As reported, it was possible that he was going to have serious consequences without intervention, but it was impossible to know for sure.The outcome of the events was left unchanged.Internal database correction performed on 05-aug-2020: the event 'accidental intra arterial injection' was re-coded from vascular occlusion to unintentional intravascular injection and initial and follow-up assessment were amended accordingly.Follow-up information was received on 06-aug-2020: the batch record review was received and the lot number for radiesse(+)® was confirmed as 100124937 (expiry date 09/2021).A lot search in the global safety database was conducted.

Event Description

Follow-up information was received on 18-aug-2020: the physician informed that the patient recovered.The outcome of the event accidental intra arterial injection was therefore changed from resolving to resolved, in 2020.

• 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
• MDR Report Key: 10407770
• MDR Text Key: 208124788
• Report Number: 3013840437-2020-00074
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: M2138063M4K12
• UDI-Public: +M2138063M4K12/$$0921100124937Y
• Combination Product (y/n): N
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/14/2021
• Device Catalogue Number: 8063M4K1
• Device Lot Number: 100124937
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCURRENT MEDICATIONS NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR