FDA Adverse Event
Injury
Summary report: N
REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML
MDR report key: 19924214
·
Received August 6, 2024
Report
- Report Number
- 3004423487-2024-00017
- Event Type
- Injury
- Date Received
- August 6, 2024
- Report Date
- August 6, 2024
- Manufacturer
- PROLLENIUM MEDICAL TECHNOLOGIES INC.
- Product Code
- LMH
- UDI-DI
- 10669808001038
- PMA / PMN Number
- P160042 S004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML,21E014 ON (B)(6) 2022 ON THE VERSA, 0.3ML OF PRODUCT WAS INJECTED. THE PATIENT REPORTS TO THE INJECTOR THAT SHE HAS DEVELOPED BUMPS ON HER LIPS A YEAR LATER. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517761 | REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML | REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML | LMH | PROLLENIUM MEDICAL TECHNOLOGIES INC. | PN40083 | 21E014 | 10669808001038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other| O |