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U.S. Department of Health and Human Services

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

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MERZ NORTH AMERICA, INC RADIESSE (+) INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 8063M15K1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 06/11/2021
Event Type  Injury  
Event Description
This mdr is related to mdr 3013840437-2021-00243 referring to the same patient. This consumer report was received from a (b)(6) consumer and concerns a male patient. He was injected with radiesse. After the radiesse injection, the patient experienced nodules. He wanted to know the treatment for that. The outcome of the event was unknown. Follow-up information was received on 07-oct-2021: the events very swollen and bowling felt very hard were added. Off label use of device and product preparation issue were added. The patients initials, year of birth and age were provided. The patient was (b)(6) also reported as (b)(6) ) male patient. He was injected with radiesse, into the gluteal area (off label use of device), on (b)(6) 2021. Radiesse was hyper-diluted 1:4 (product preparation issue). The patient had atrophic scars that were treated (ambiguously reported as subscised) with a nokor needle, radiesse was placed with a cannula in the form of large boluses in the scars, and radiesse was injected in the form of pellets on more superficial scars (as reported). The patient was previously injected with sculptra, into the left gluteus. On (b)(6) 2021, after the radiesse injection, the patient experienced that it was very swollen and bowling felt very hard, especially where the patient had larger radiesse bowls. The shallow bowls did not improve. The biggest bowls started to decrease, but then stopped decreasing, they never went down to zero (as reported). Approximately 10 days later, the patient had a first check-up with the physician. The physician massaged the boluses and applied collagenase injection to the most superficial nodules for treatment (reported as to lower them), with little effect. Saline solution plus collagenase was injected to all the boluses, 15 days later. The bowls did not go down considerably. The patient's physician applied carboxytherapy and collagenase saline to degrade nodules, twice a week, with little effect, on the size of the nodules, for 2 months. The patient went to another physician and she sent him to perform an ultrasound (skin echotomography). The patient was diagnosed with nodules due to the reaction to a foreign body (hydroxyapatite). On (b)(6) 2021, skin echotomography showed that the left gluteal region was explored in the area of palpable nodular lesion. At this location on the plane dermo-hypodermic, a pseudo-nodular image was identified with focal thickening of the plane dermal with increased echogenicity and loss of dermo hypodermic differentiation. Superficial hypodermis showed decreased echogenicity in this location, the lesion measures 20 x 4. 2 x 18 mm in the transverse, anteroposterior and longitudinal axes respectively. Discreet increased vascularity of the dermal plane in this location. There were no calcifications or collection formation. Pseudo-nodular image in the dermo-hypodermic plane of the left gluteal region, with the appearance of foreign body reaction. The patient was treated with atrinat (triamcinolone) injectable. Many blouses were solved but there were some that persisted, especially the largest and they were very superficial. The patient had boluses for almost 4 months and wanted to see other non-surgical treatment options (intralesional fiber optic laser, substitution, corticosteroids). The outcome of the event nodule / bowling felt very hard was considered as resolving. The outcome of remining events was unknown. Follow-up information was received on 20-oct-2021: the suspect product was changed from radiesse to radiesse+. The patient was injected with radiesse+. The batch record review was received and the lot number for radiesse+ was confirmed as a00011550 (expiry date:04/2023). A lot search in the global safety database was conducted. The outcome of the events remained unchanged. Follow-up information was received on (b)(6) 2021: this case was upgraded to serious. The event foreign body reaction/ inflammation/ fibrosis was added. The events very swollen and bowling felt very hard were deleted, they were considered to be symptoms of the foreign body reaction/ inflammation/ fibrosis. The event term nodule was amended to nodules/ accumulation of the product, and it was recoded from injection site nodule to product distribution issue. The patient did not know what diluent was used for the hyper dilution. He imagined that it was lidocaine with a sterile solution. Sculptra was injected for the same purpose as radiesse(+), to improve the quality of the skin due to acne scars on the buttock, 8 months prior. Radiesse(+) was chosen as a continuation of the treatment. As reported, it was different since it did not have to reacted. A sculptra granuloma had the possibility to form months later, but the nodules occurred right where radiesse(+) was injected. The patient previously had an external aesthetic treatment with a laser, without complication. The patients medical history included acne and acne scars in the gluteal area. Corrective treatment included a triamcinolone injection and intralesional laser with an acutitte platform, to degrade nodules with heat. Several nodules disappeared after the application of triamcinolone. The patient evolved with it, and hoped it worked. A biopsy, or more research was not performed, but the patient went through three physicians. As reported, the nodules were immediate post injection, therefore it was the radiesse(+) (reacting as a foreign body), since the injection was in the form of boluses and not in vectors. The diagnosis was that it was radiesse(+) that generated inflammation, due to the way in which it was injected, and that the accumulation of the product was forming nodules. The foreign body reaction was from radiesse(+) and not from sculptra, since the nodules formed immediately after the injection and never subsided after that. It was the product that was condensed in that place, in the form of boluses, and since radiesse(+)was dense and had g prime, it formed that type of fibrosis in the body to encapsulate hydroxyapatite, which was not able to be seen on ecotomogrhapy. Only the skin thickened, and calcium particles had to be seen on an x-ray. At the time of this report, the patient had two smaller nodules uperficial, and 3 deeper ones. The two small ones were the size of a lentil and the 3 larger ones were the size of a small grape. At the time of this report, the patient still took treatment for nodules. He continued with the intralesional corticosteroid injection or nodule subcision (as reported). As reported, the patient talked about the nodules with several physicians who used radiesse, and they had no idea how to treat them, therefore, the patient and his physician wanted to see treatment alternatives with which an improvement was going to be expected. The patient investigated reports of physicians who treated these nodules, but they were mostly experimental treatments. The outcome of the event foreign body reaction/ inflammation/ fibrosis was unknown. The outcome of the event nodules/ accumulation of the product was left unchanged. As reported, the patient hoped that corrective treatment was performed to avoid permanent damage, and that the result was not permeant (considered as permanent). Idbc was performed on (b)(6) 2021: within the scope of case processing it was discovered that the expiry date of radiesse+ lot number a00011550 of 04/2023 was incorrect and updated to 03/2023.
 
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, foreign body reaction/ inflammation/ fibrosis (foreign body reaction) was deemed to meet serious criteria of required intervention to prevent permanent damage; and disability or permanent damage. The device history record for radiesse (+) lot number a00011550 was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. No nonconformances were noted that would have contributed to this event.
 
Event Description
This mdr is related to mdr 3013840437-2021-00243 referring to the same patient. This consumer report was received from a (b)(6) consumer and concerns a male patient. He was injected with radiesse. After the radiesse injection, the patient experienced nodules. He wanted to know the treatment for that. The outcome of the event was unknown. Follow-up information was received on 07-oct-2021: the events very swollen and bowling felt very hard were added. Off label use of device and product preparation issue were added. The patients initials, year of birth and age were provided. The patient was (b)(6) also reported as (b)(6) ) male patient. He was injected with radiesse, into the gluteal area (off label use of device), on (b)(6) 2021. Radiesse was hyper-diluted 1:4 (product preparation issue). The patient had atrophic scars that were treated (ambiguously reported as subscised) with a nokor needle, radiesse was placed with a cannula in the form of large boluses in the scars, and radiesse was injected in the form of pellets on more superficial scars (as reported). The patient was previously injected with sculptra, into the left gluteus. On (b)(6) 2021, after the radiesse injection, the patient experienced that it was very swollen and bowling felt very hard, especially where the patient had larger radiesse bowls. The shallow bowls did not improve. The biggest bowls started to decrease, but then stopped decreasing, they never went down to zero (as reported). Approximately 10 days later, the patient had a first check-up with the physician. The physician massaged the boluses and applied collagenase injection to the most superficial nodules for treatment (reported as to lower them), with little effect. Saline solution plus collagenase was injected to all the boluses, 15 days later. The bowls did not go down considerably. The patient's physician applied carboxytherapy and collagenase saline to degrade nodules, twice a week, with little effect, on the size of the nodules, for 2 months. The patient went to another physician and she sent him to perform an ultrasound (skin echotomography). The patient was diagnosed with nodules due to the reaction to a foreign body (hydroxyapatite). On (b)(6) 2021, skin echotomography showed that the left gluteal region was explored in the area of palpable nodular lesion. At this location on the plane dermo-hypodermic, a pseudo-nodular image was identified with focal thickening of the plane dermal with increased echogenicity and loss of dermo hypodermic differentiation. Superficial hypodermis showed decreased echogenicity in this location, the lesion measures 20 x 4. 2 x 18 mm in the transverse, anteroposterior and longitudinal axes respectively. Discreet increased vascularity of the dermal plane in this location. There were no calcifications or collection formation. Pseudo-nodular image in the dermo-hypodermic plane of the left gluteal region, with the appearance of foreign body reaction. The patient was treated with atrinat (triamcinolone) injectable. Many blouses were solved but there were some that persisted, especially the largest and they were very superficial. The patient had boluses for almost 4 months and wanted to see other non-surgical treatment options (intralesional fiber optic laser, substitution, corticosteroids). The outcome of the event nodule / bowling felt very hard was considered as resolving. The outcome of remaining events was unknown. Follow-up information was received on 20-oct-2021: the suspect product was changed from radiesse to radiesse+. The patient was injected with radiesse+. The batch record review was received and the lot number for radiesse+ was confirmed as a00011550 (expiry date:04/2023). A lot search in the global safety database was conducted. The outcome of the events remained unchanged. Follow-up information was received on 20-oct-2021: this case was upgraded to serious. The event foreign body reaction/ inflammation/ fibrosis was added. The events very swollen and bowling felt very hard were deleted, they were considered to be symptoms of the foreign body reaction/ inflammation/ fibrosis. The event term nodule was amended to nodules/ accumulation of the product, and it was recoded from injection site nodule to product distribution issue. The patient did not know what diluent was used for the hyper dilution. He imagined that it was lidocaine with a sterile solution. Sculptra was injected for the same purpose as radiesse(+), to improve the quality of the skin due to acne scars on the buttock, 8 months prior. Radiesse(+) was chosen as a continuation of the treatment. As reported, it was different since it did not have to reacted. A sculptra granuloma had the possibility to form months later, but the nodules occurred right where radiesse(+) was injected. The patient previously had an external aesthetic treatment with a laser, without complication. The patients medical history included acne and acne scars in the gluteal area. Corrective treatment included a triamcinolone injection and intralesional laser with an acutitte platform, to degrade nodules with heat. Several nodules disappeared after the application of triamcinolone. The patient evolved with it, and hoped it worked. A biopsy, or more research was not performed, but the patient went through three physicians. As reported, the nodules were immediate post injection, therefore it was the radiesse(+) (reacting as a foreign body), since the injection was in the form of boluses and not in vectors. The diagnosis was that it was radiesse(+) that generated inflammation, due to the way in which it was injected, and that the accumulation of the product was forming nodules. The foreign body reaction was from radiesse(+) and not from sculptra, since the nodules formed immediately after the injection and never subsided after that. It was the product that was condensed in that place, in the form of boluses, and since radiesse(+)was dense and had g prime, it formed that type of fibrosis in the body to encapsulate hydroxyapatite, which was not able to be seen on ecotomogrhapy. Only the skin thickened, and calcium particles had to be seen on an x-ray. At the time of this report, the patient had two smaller nodules superficial, and 3 deeper ones. The two small ones were the size of a lentil and the 3 larger ones were the size of a small grape. At the time of this report, the patient still took treatment for nodules. He continued with the intralesional corticosteroid injection or nodule subcision (as reported). As reported, the patient talked about the nodules with several physicians who used radiesse, and they had no idea how to treat them, therefore, the patient and his physician wanted to see treatment alternatives with which an improvement was going to be expected. The patient investigated reports of physicians who treated these nodules, but they were mostly experimental treatments. The outcome of the event foreign body reaction/ inflammation/ fibrosis was unknown. The outcome of the event nodules/ accumulation of the product was left unchanged. As reported, the patient hoped that corrective treatment was performed to avoid permanent damage, and that the result was not permeant (considered as permanent). Idbc was performed on (b)(6) 2021: within the scope of case processing it was discovered that the expiry date of radiesse+ lot number a00011550 of 04/2023 was incorrect and updated to 03/2023.
 
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, foreign body reaction/ inflammation/ fibrosis (foreign body reaction) was deemed to meet serious criteria of required intervention to prevent permanent damage; and disability or permanent damage. The device history record for radiesse (+) lot number a00011550 was reviewed. A lot search was conducted on the reported lot and no other similar events were noted. No nonconformances were noted that would have contributed to this event.
 
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Brand NameRADIESSE (+) INJECTABLE IMPLANT
Type of DeviceIMPLANT, 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 Key13011692
MDR Text Key285931884
Report Number3013840437-2021-00242
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number8063M15K1
Device Lot NumberA00011550
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
Treatment
CONCOMITANT DRUG NOT AVAILABLE
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