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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 Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 09/08/2020
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
He clinic reports that the patient was injected with revanesse versa+ with lidocaine (lot 20g008) to the nasolabial folds on (b)(6) 2020 utilizing the entire 1ml syringe during injection. The patient presented several hours after injection with redness and burning at the site of the injection that continued to spread down her face and her neck. The redness was present on both sides of her face. Patient has no allergies and the only medication taken is a multi-vitamin. On the query of the medical director, a confirmation was received to rule out an intra vascular occlusion. The clinic responded suspecting this is a histamine reaction. Followup indicated that she was treated with steroid pack that cleared her skin but still had a red line from cheek down her neck. A topical anesthetic compound cream of 20% benzocaine, 6% lidocaine and 4% tetracaine was used. Medical director summarises that the 20% benzocaine ester anesthetic would be the most likely to trigger the patients histaminic erythema. Any residual erythema could be caused by pih.
 
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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, ontario 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 Key10671291
MDR Text Key211334131
Report Number3004423487-2020-00010
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 company representative,health
Reporter Occupation Administrator/Supervisor
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/02/2021
Device Model NumberPN40082
Device Catalogue NumberPN40082
Device Lot Number20G008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2020 Patient Sequence Number: 1
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