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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE LIPS+ 1.0 ML

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PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE LIPS+ 1.0 ML Back to Search Results
Model Number 40144
Device Problems Device Appears to Trigger Rejection (1524); Migration (4003)
Patient Problems Deformity/ Disfigurement (2360); Nodule (4551); Swelling/ Edema (4577)
Event Date 10/09/2021
Event Type  Injury  
Manufacturer Narrative
The clinical complaint has been adequately investigated. The lot number has been verified and has been confirmed to be released by the company. It has been confirmed that one previous clinical complaint has been found for the particular lot number in question. The batch record, qc test reports, and training of staff were analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures. Prollenium medical technologies' medical director's response to this adverse event was provided to the clinic: "the following is a clinical opinion based on the information and photos provided in the complaint outlined below; on (b)(6) 2021 1ml of versa was injected into the lips. The lips were "massaged" post injection. There is no evidence of an allergic reaction or inflammatory response. There is no history or photos showing nodules or erythema however the patient almost immediately felt the results were asymmetric and "lumpy". This is verified in the photos provided. The photos all show bruising and significant asymmetry which is most pronounced on the upper lip. The product in both the upper and lower lips has been deposited in boluses at a very superficial level, to the point that it can be seen thru the thin epithelium of the lip. Once again there are no nodules or inflammation. The thorough history and multiple photos make it much easier to offer a clinical opinion. This case represents a sub optimal injection technique with product having been injected asymmetrically, too superficial and in boluses that are too large. It is worth noting that it is a relative contraindication to deposit a different ha on top of other products such as vobella, vollure and restyllane as this has not been studied so no safety data exists. Fortunately, i see no evidence that a reaction has occurred. Massaging the thin lip tissue can cause bruising and minimal product movement especially when it is deposited this superficial. I see no evidence of an adverse event related to product. This case clearly represents a sub optimal injection which can usually only be corrected by dissolving the superficial product. I hope this clinical opinion is of value to all parties concerned. ".
 
Event Description
Hold for as 02. 16. Based on the information provided from the clinic, on (b)(6) 2021 - date of treatment with revanesse lips+ injected in the lips area of the patient. The volume injected is 1. 0 ml. Patient is (b)(6). (date of birth: (b)(6)). Not first dermal filler treatment. Patient has had restylane l, restylane kysse, volbella, and vollure in the lips before and have had different ha filled in the same area in the past with no complications. According to the injector, patient had no pre-existing risk factors. No allergies to dermal filler treatments reported. Elevated fitzpatrick scale: 2. Medications after/before the treatment: birth control "errin". Patient has been vaccinated with covid-19 moderna vaccine (1st dose: (b)(6) 2021; 2nd dose: (b)(6) 2021). Patient received a flu shot on (b)(6) 2021. No other shots/medications as reported. Topical anesthetic used: 2% lidocaine injected - dental block + topical 23% lidocaine/7% prilocaine patient is scheduled to have hyaluronidase. As reported by injector, injection in lips using the product with the syringe in the packaging. Lidocaine, both topical and dental block was used for numbing. Product injected in both upper and lower lips. The full syringe was used and massage was done after the filler was injected. Patient had some swelling directly after the injection. The day after there were lumps on both lower and upper lips. R side on the upper lip more swollen than on the l upper. The lips especially the upper got very hard when the product is located, the lower have a more bumpy appearance and will do. The product also migrated a lot on the upper lips, but no filler was injected in that area. Patient still has the same issues, and will have to use hylenex to dissolve all filler. Filler was injected (b)(6) 2021 so 2 weeks ago with no change. Current status of the patient: still have hard bumps and swelling on both the upper and lower lips. Upper lips are worse than lower.
 
Event Description
Based on the information provided from the clinic, on (b)(6) 2021 - date of treatment with revanesse lips+ injected in the lips area of the patient. The volume injected is 1. 0 ml. Patient is (b)(6). (date of birth: (b)(6)). Not first dermal filler treatment. Patient has had restylane l, restylane kysse, volbella, and vollure in the lips before and have had different ha filled in the same area in the past with no complications. According to the injector, patient had no pre-existing risk factors. No allergies to dermal filler treatments reported. Elevated fitzpatrick scale: 2. Medications after/before the treatment: birth control "errin". Patient has been vaccinated with covid-19 moderna vaccine (1st dose: (b)(6) 2021; 2nd dose: (b)(6) 2021). Patient received a flu shot on (b)(6) 2021. No other shots/medications as reported. Topical anesthetic used: 2% lidocaine injected - dental block + topical 23% lidocaine/7% prilocaine patient is scheduled to have hyaluronidase. As reported by injector, injection in lips using the product with the syringe in the packaging. Lidocaine, both topical and dental block was used for numbing. Product injected in both upper and lower lips. The full syringe was used and massage was done after the filler was injected. Patient had some swelling directly after the injection. The day after there were lumps on both lower and upper lips. R side on the upper lip more swollen than on the l upper. The lips especially the upper got very hard when the product is located, the lower have a more bumpy appearance and will do. The product also migrated a lot on the upper lips, but no filler was injected in that area. Patient still has the same issues, and will have to use hylenex to dissolve all filler. Filler was injected (b)(6) 2021 so 2 weeks ago with no change. Current status of the patient: still have hard bumps and swelling on both the upper and lower lips. Upper lips are worse than lower.
 
Manufacturer Narrative
The clinical complaint has been adequately investigated. The lot number has been verified and has been confirmed to be released by the company. It has been confirmed that one previous clinical complaint has been found for the particular lot number in question. The batch record, qc test reports, and training of staff were analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures. Prollenium medical technologies' medical director's response to this adverse event was provided to the clinic: "the following is a clinical opinion based on the information and photos provided in the complaint outlined below; on (b)(6) 2021 1ml of versa was injected into the lips. The lips were "massaged" post injection. There is no evidence of an allergic reaction or inflammatory response. There is no history or photos showing nodules or erythema however the patient almost immediately felt the results were asymmetric and "lumpy". This is verified in the photos provided. The photos all show bruising and significant asymmetry which is most pronounced on the upper lip. The product in both the upper and lower lips has been deposited in boluses at a very superficial level, to the point that it can be seen thru the thin epithelium of the lip. Once again there are no nodules or inflammation. The thorough history and multiple photos make it much easier to offer a clinical opinion. This case represents a sub optimal injection technique with product having been injected asymmetrically, too superficial and in boluses that are too large. It is worth noting that it is a relative contraindication to deposit a different ha on top of other products such as vobella, vollure and restyllane as this has not been studied so no safety data exists. Fortunately, i see no evidence that a reaction has occurred. Massaging the thin lip tissue can cause bruising and minimal product movement especially when it is deposited this superficial. I see no evidence of an adverse event related to product. This case clearly represents a sub optimal injection which can usually only be corrected by dissolving the superficial product. I hope this clinical opinion is of value to all parties concerned. ".
 
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Brand NameREVANESSE LIPS+ 1.0 ML
Type of DeviceREVANESSE LIPS+ 1.0 ML
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway n
aurora, on L4G 4 C3
CA L4G 4C3
Manufacturer Contact
ario khoshbin
138 industrial parkway n
aurora, on 
CA  
MDR Report Key12853004
MDR Text Key285925330
Report Number3004423487-2021-00022
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P160042 S010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number40144
Device Lot Number21B032
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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