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U.S. Department of Health and Human Services

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

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PROLLENIUM MEDICAL TECHNOLOGIES INC., REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML Back to Search Results
Model Number PN40082
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
The clinical complaint was adequately investigated. The lot number was verified and has been confirmed to be released by the company. It was observed that there has been a prior complaint (ref: (b)(4)) associated with lot# 20f030. The batch record, qc test reports, and training of staff were analyzed and it has been determined that product is within required specifications, and manufactured according to the appropriate procedures.
 
Event Description
The clinic's medical director reported to the manufacturer that the patient, female was injected with 3 syringes of revanesse versa+ (with lidocaine); lot number 20f030 to correct an old past traumatic indentation in the left cheek, lips and naso labial folds. The patient return to the practice the next day with an allergic reaction to her face. He also reported without specifics that he has been treating her conservatively and has been seeing improvements. Medical director was consulted for his opinion and his clinical assessment is that it is more likely to be a reaction to a topical agent. The medical director's response was sent to the clinic on 14 oct 2020. The clinic medical director informed prollenium on 12 oct 2020 that he is waiting for a follow up with patient to respond to the information requested by prollenium on adverse event. No response was provided to date. Manufacturer will continue to communicate with the clinic.
 
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Brand NameREVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML
Type of DeviceREVANESSE VERSA+
Manufacturer (Section D)
PROLLENIUM MEDICAL TECHNOLOGIES INC.,
138 industrial parkway north
aurora, on L4G 4 C3
CA L4G 4C3
Manufacturer (Section G)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway north
aurora, on L4G 4 C3
CA L4G 4C3
Manufacturer Contact
ario khoshbin
138 industrial parkway north
aurora, on L4G 4-C3
CA   L4G 4C3
MDR Report Key10730921
MDR Text Key212992595
Report Number3004423487-2020-00012
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
160042/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/04/2021
Device Model NumberPN40082
Device Catalogue NumberPN40082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2020
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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