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

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.

• Brand Name: REVANESSE VERSA+ WITH LIDOCAINE
• Type of Device: REVANESSE 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 Key: 10260941
• MDR Text Key: 202687114
• Report Number: 3004423487-2020-00007
• 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: 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 Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/17/2020
• Device Model Number: PN40083
• Device Lot Number: 19J057
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2020
• Device Age: 10 MO
• Event Location: Other
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2019
• 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