FDA Adverse Event
Injury
Summary report: N
JUVEDERM (VOLUME/CONCENTRATION UNKNOWN)
MDR report key: 4132722
·
Received September 29, 2014
Report
- Report Number
- 3005113652-2014-00473
- Event Type
- Injury
- Date Received
- September 29, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 2, 2014
- Manufacturer
- ALLERGAN
- Product Code
- LMH
- PMA / PMN Number
- P050047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THERE ADDITIONAL EVENT AND PRODUCT DETAILS ARE NOT ATTAINABLE. THE EVENTS OF "MIGRATED" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: THE ONSET OF DISPLACEMENT GENERALLY VARIED FROM IMMEDIATE TO 2 WEEKS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED ANTIBIOTICS, STEROIDS, HYALURONIDASE, AND LASER TREATMENT.
Description of Event or Problem · 1
PATIENT REPORTED THAT AFTER INJECTION WITH AN UNSPECIFIED JUVEDERM PRODUCT IN AN UNKNOWN LOCATION, THE PRODUCT MIGRATED INTO THE LIPS. THE PATIENT HAS RECEIVED ORAL SURGERY AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 604338 | JUVEDERM (VOLUME/CONCENTRATION UNKNOWN) | LMH | ALLERGAN | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |