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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 Problems Reaction (2414); Swelling/ Edema (4577)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
The clinical complaint was adequately investigated. 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 product is within required specifications and manufactured according to the appropriate procedures.
 
Event Description
The nurse injector reported that the patient, female (b)(6) was injected on (b)(6) 2020 with 0. 5 ml of revanesse versa+ with lidocaine into the lips. Swelling was present but within normal limits until she left. By 7pm that night, her upper lip started to swell. The patient applied ice, used benadryl and tylenol/ibuprofen. She was doing better the following morning but she wanted to consult with the manufacturer. The patient has a history of hypertension, treated with lisinopril. No other medical history reported. Nurse injector used a compounded topical cream was used- benzocaine, lidocaine & tetracaine. The medical director was contacted and his evaluation is that the swelling seen in the photos provided, coupled with the brief duration and ease of treatment ( ice and benadryl) suggests that this is not an allergic reaction. He believes the swelling was enhanced by use of a topical anesthetic and lisinopril ( ace inhibitor) causes increased levels of bradykinins, hence the edema. The nurse injector reported on 08-dec-2020 that the patient was doing better now, swelling has resolved completely.
 
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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 L4C5N 8
CA L4C5N8
Manufacturer (Section G)
PROLLENIUM MEDICAL TECHNOLOGIES INC.
138 industrial parkway north
aurora, on L4C5N 8
CA L4C5N8
Manufacturer Contact
ario khoshbin
138 industrial parkway north
aurora, on L4C5N-8
CA   L4C5N8
MDR Report Key11059681
MDR Text Key224244929
Report Number3004423487-2020-00018
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P160042/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/03/2021
Device Model NumberPN40082
Device Catalogue NumberPN40082
Device Lot Number20F029
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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