MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML

Model Number PN40082

Device Problem Use of Device Problem (1670)

Patient Problems Headache (1880); Visual Impairment (2138); Weakness (2145); Dizziness (2194)

Event Date 09/27/2020

Event Type  Injury  

Manufacturer Narrative

The clinical compliant was adequately investigated.The lot number was verified and has been confirmed to be released by the company.It has been confirmed that no previous clinical complaints have been found for the particular lot number in question.The batch record, qc test reports and training of staff were analyzed and it has been determined that the product is within required specifications, and manufactured accordingly to the appropriate procedures.

Event Description

Patient a (b)(6) year old female, was injected at with revanesse versa + with lidocaine (1ml), lot number 20g100 on (b)(6) 2020 on the lips, volume was unspecified.Patient went to the hospital on the (b)(6) 2020 reporting the following adverse event symptoms (1) vision changes (2) arms and legs weakness, (3) headache, (4) dizziness.Patient contacted manufacturer via telephone on 27-sep-2020.Manufacturer's follow up with the clinic (28 sep 2020) showed that patient was previously injected on (b)(6) 2020 at the same clinic ((b)(6)) using juvederm dermal filler.The clinic indicated the patient had a rash following a treatment and had been taking naproxen and excedrin.Regarding the (b)(6) 2020 treatment no notable ae or medication was recorded on the patient file.Medical director was contacted and based on the report provided by the medical director the timing (2+ weeks) and the non specific nature of the reported symptoms, he does not see any correlation with the lip injection two weeks prior.In this case the revanesse versa+ was injected into the lips which is an unapproved area of injection for revanesse versa+.The patient was contacted on 06-sep-2020 for a followup on her current status.No response was received.Manufacturer reached out to the clinic on 30-sep-2020, 06-oct-2020, 07-oct-2020, 13-oct-2020, 14-oct-2020 & 20-oct-2020 for information on follow up with patient.No response was received to date.

• Brand Name: REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML
• Type of Device: REVANESSE VERSA+
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway north; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIES INC.,; 138 industrial parkway north,; aurora, ontario L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway north,; aurora, ontario L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 10711141
• MDR Text Key: 212458890
• Report Number: 3004423487-2020-00011
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160042/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: PN40082
• Device Catalogue Number: PN40082
• Device Lot Number: 20G100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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
• Patient Age: 26 YR