REVANESSE VERSA
Received Nov 26, 2019
Report 3004423487-2019-00006 · MDR key 9378899
Device
Generic name
Revanesse Versa
Manufacturer
Prollenium Medical Technologies IncModel number
40081Lot number
18G065
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Bruise/Contusion
- Swelling
- Bruise/Contusion
- Swelling
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORD SUMMARY: THE RETROSPECTIVE REVIEW OF THE BATCH RECORD SHOWS THAT NO ELEMENT CAUSING THE ISSUE. ALL QUALITY CONTROL HAVE PASSED AND THERE WAS NO LIDOCAINE CONTAIN ADDED. EACH OF THE SYRINGE WERE VISUALLY INSPECTED AFTER FILLING AND NO CONTAMINATION WERE DETECTED.
Description of Event or Problem
THE PATIENT GOT HER INJECTION (REVANESSE VERSA - LOT 18G065) ON (B)(6) 2018. INITIALLY THERE WERE BRUISING AND SOME LUMP UNDER HER EYES. AFTER TWO AND A HALF WEEKS LATER THE LUMP WENT DOWN BUT STILL RETAINED SOME PUFFINESS. THE PATIENT WAS CONCERNED ABOUT THOSE IRREGULAR LUMP / PUFFINESS UNDER HER EYES, BECAUSE SHE WAS ABLE TO SEE THE PUFFINESS UNDER HER EYES WITH HER PERIPHERAL VISION WHEN SHE WAS SITTING DOWN. THE PATIENT THINKS THE SITUATION WAS GETTING WORSE, THAT HER VISION WAS BEING AFFECTED TOO.
Additional Manufacturer Narrative
1 .CORRECTION TO SECTION E1 FROM INITIAL REPORT:- CHANGED THE MDR REPORTER COUNTRY FROM CANADA TO USA.