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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ WITH LIDOCAINE

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PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE VERSA+ WITH LIDOCAINE Back to Search Results
Model Number PN40083
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Itching Sensation (1943); Reaction (2414)
Event Date 06/11/2020
Event Type  Injury  
Manufacturer Narrative
Patient was injected revanesse versa+ with lidocaine (19j057) into nasolabial folds in (b)(6) 2020. Patient presented with 2 - itchy, non - tender nodules under skin approximately 1-2 days post injection. Both nodules on one side with some bruising. According to medical director it is a reaction to chlorhexidine preparation but the medical director wanted to check before reversing with hylenex. It seems too close to procedure to be infection. The batch record and test report for the lot 19j057 were checked and verified. The certificate of analysis, manufacturing batch record checklist, quality control test report and packaging documents were checked and did not find any irregularities in the records. All the records were in compliance with the standards specifications and product has passed. There is no deviation or ncr was associated with this lot. According to the injector and manufacturer's medical director's assessment, the allergic reactions were mainly due to the chlorhexidine topical disinfectant. The injector informed to the manufacturer's quality department that the pruritus has resolved and the patient is happy with the result.
 
Event Description
Patient was injected revanesse versa+ with lidocaine (19j057) into nasolabial folds in (b)(6) 2020. Patient presented with 2 - itchy, non - tender nodules under skin approximately 1-2 days post injection. Both nodules on one side with some bruising. According to medical director it is a reaction to chlorhexidine preparation but the medical director wanted to check before reversing with hylenex. It seems too close to procedure to be infection.
 
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Brand NameREVANESSE VERSA+ WITH LIDOCAINE
Type of DeviceREVANESSE VERSA+ WITH LIDOCAINE
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
colin hall
138, industrial parkway north
aurora, ontario L4G 4-C3
CA   L4G 4C3
MDR Report Key10260941
MDR Text Key202687114
Report Number3004423487-2020-00007
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160042 S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/17/2020
Device Model NumberPN40083
Device Lot Number19J057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/15/2020
Device Age10 MO
Event Location Other
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2019
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: 07/10/2020 Patient Sequence Number: 1
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