REVANESSE VERSA
Received Jan 11, 2019 · Event occurred Jul 23, 2018
Report 3004423487-2009-00003 · MDR key 8242078
Device
Generic name
Dermal Filler
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40081Lot number
18F032
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Anaphylactic Shock
- Edema
- Nausea
- Respiratory Distress
- Tachycardia
- Vomiting
- Anaphylactic Shock
- Edema
- Nausea
- Respiratory Distress
- Tachycardia
- Vomiting
Narrative
Additional Manufacturer Narrative
[(B)(4)].
Description of Event or Problem
PATIENT WAS INJECTED REVANESSE VERSA INTO THE LIPS, WHICH THE NURSE HAD MISSED WITH 0.2CC OF 1% LIDOCAINE. THE PATIENT ALSO RECEIVED A CREAM ON THE LIPS WHICH CONTAINED 23% LIDOCAINE MIXED WITH 7% TETRACAINE POWDER. PATIENT HAD AN ACUTE ANAPHYLACTIC REACTION GETTING INJECTED INTO THE LIPS, THE SYMPTOMS OF THE PATIENT INCLUDE UPPER AIRWAY EDEMA, SHORTNESS OF BREATH, NAUSEA, VOMITING AND TACHYCARDIA. DURING THE TIME IN THE HOSPITAL THE PATIENT HAD RECEIVED EPI PEN0.3MG IM, PEPCID 20MG IM AND SOLU MEDROL 125MG IM IN THE URGENT CARE. LATER ON SHE WS ALSO GIVEN ZYRTEC, PEPCID, PREDNISONE AND AN ALBUTEROL TREATMENT. PATIENT WAS DISCHARGED TO HOME WITH NO FURTHER ISSUES AND BACK TO WORK NORMALLY.