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

Model Number	8071M0K1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria of necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record for radiesse dermal filler lot 100089473 was reviewed.No non-conformances were noted that would have contributed to this event.A lot search was conducted on the reported lot and no similar events were noted.
Event or Problem Description
This spontaneous report was received from a (b)(6)-year-old female patient, a nurse practitioner, who was injected with 1cc of radiesse about one month ago for hands indication.Concomitant medication reported as synthroid (levothyroxine).Medical history positive for sulfa allergy.Right after injection (also reported as (b)(6) 2018), the patient experienced swelling, pinkness and pain to the right hand.It was so painful, she could not sleep that night.The following day, she developed the same symptoms in her left hand.An orthopedic surgeon friend thought she had cellulitis and started her on an unspecified broad spectrum antibiotic.She did not otherwise see a physician.Reporter clarified the antibiotic was not started as a prophylactic measure but as treatment.The patient experienced improvement in her symptoms "right after" starting antibiotic.The symptoms were resolved after three weeks.Lot number reported as 100089473.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• MDR Report Key: 7327336
• Report Number: 2135225-2018-00010
• Device Sequence Number: 147933
• Product Code: PKY
• UDI-Device Identifier: M2138071M0K15
• UDI-Public: +M2138071M0K15/$$31903161000894735
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: 8071M0K1
• Device Catalogue Number: 8071M0K1
• Device Lot Number: 100089473
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHROID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR