REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML
Received Dec 22, 2020 · Event occurred Oct 1, 2020
Report 3004423487-2020-00017 · MDR key 11059676
Device
Generic name
Revanesse Versa+
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40082Catalog number
PN40082
Lot number
20G100
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Swelling/ Edema
- Swelling/ Edema
Narrative
Additional 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.
Description of Event or Problem
THE NURSE INJECTOR REPORTED THAT THE PATIENT, HAD THE TREATMENT IN OCTOBER AND CONTINUES TO HAVE PERSISTENT SWELLING TO DATE.
Remedial action
- Patient Monitoring