BELLAFILL DERMAL FILLER
Report
- Report Number
- 3003707320-2017-00010
- Event Type
- Injury
- Date Received
- July 11, 2017
- Date of Event
- June 7, 2017
- Report Date
- July 7, 2017
- Manufacturer
- SUNEVA MEDICAL, INC.
- Product Code
- LMH
- PMA / PMN Number
- P020012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
FOLLOW UP #2 SUBMITTED 09/24/2018: ON 08/21/2018, SUNEVA RECEIVED MW5071520-1, WHERE THE PATIENT ADDS THAT SHE WAS ON ANTIBIOTICS FOR MONTHS BEFORE SHE FOUND A DOCTOR WHO AGREED TO REMOVE THE DERMAL FILLER FROM HER FACE. SHE HAD THE FILLER REMOVED. A DATE OF REMOVAL WAS NOT PROVIDED. NO OTHER CHANGES TO PRIOR EMDR SUBMISSION FOLLOW UP #1.
FOR THIS FOLLOW UP SUBMISSION (#2): ON 08/21/2018, SUNEVA RECEIVED MW5071520-1, WHERE THE PATIENT ADDS THAT SHE WAS ON ANTIBIOTICS FOR MONTHS BEFORE SHE FOUND A DOCTOR WHO AGREED TO REMOVE THE DERMAL FILLER FROM HER FACE. SHE HAD THE FILLER REMOVED. A DATE OF REMOVAL WAS NOT PROVIDED. NO OTHER CHANGES TO PRIOR EMDR SUBMISSION (FOLLOW UP #1).
RE-SUBMITTED PER HELPDESK - SAME INFO THROUGHOUT. PATIENT ((B)(6) WAS INJECTED OFF-LABEL UNDER THE EYES WITH BELLAFILL BY DR. (B)(6) ON TWO OCCASIONS: - (B)(6) 2016 WITH ONE SYRINGE OF LOT F151124, MANUFACTURE DATE: 11/06/2015, EXP DATE: 02/21/2017. - (B)(6) 2016 WITH ONE SYRINGE OF LOT F151024, MANUFACTURE DATE: 03/16/2015, EXP DATE: 07/29/2016. SUNEVA CONDUCTED A REVIEW OF BOTH LOTS. NO ISSUES WERE FOUND. THE LOT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND MET ACCEPTANCE CRITERIA AT TIME OF PRODUCT RELEASE. THE LOTS HAD SINCE EXPIRED THEREFORE RETAINED SAMPLES WERE NOT AVAILABLE FOR REVIEW. ON (B)(6) 2017, DR. (B)(6) RELAYED THAT HE SUSPECTS THE PATIENT'S SWELLING IS DUE TO A BIOFILM INFECTION THAT WAS INTRODUCED DURING THE PATIENT'S BELLAFILL INJECTIONS AND IS CAUSED BY STAPH EPI. HE BELIEVES THAT IT WILL RESOLVE OVER TIME, BUT WILL NOT RESOLVE WITHOUT TREATMENT (CURRENTLY ANTIBIOTICS AND PREDNISONE). HE STATES THERE IS NOTHING TO BIOPSY TO CONFIRM BIOFILM. HIS SUSPICION IS DUE TO THE PATIENT'S DOCUMENTED PERSISTENCE OF EDEMA. PER DR. (B)(6) INJECTOR, THE PATIENT HAS MALAR EDEMA WHICH WAS UNMASKED BY IRRITATION (IN THIS CASE, THE BELLAFILL INJECTION) AND STATES THAT THE EDEMA DUE TO THIS CONDITION TYPICALLY RESOLVES ON ITS OWN OVER TIME. PER DR. (B)(6), THE EDEMA IS 2CM ABOVE WHERE HE PLACED THE BELLAFILL. THE PATIENT WAS INJECTED UNDER THE EYES WHICH IS AN OFF-LABEL LOCATION. THE BELLAFILL INJECTOR (DR. (B)(6)) IS AWARE OF BELLAFILL INDICATIONS FOR USE. INJECTOR CONTACT INFO: (B)(6). THE PATIENT SAW ANOTHER DOCTOR, DR. (B)(6), AROUND (B)(6) 2017, WHO RECENTLY CALLED SUNEVA STATING THAT SHE IS NOT CONVINCED THIS IS BELLAFILL-RELATED. THE PATIENT'S STARTING ANATOMY HAD BEEN CHANGED PRIOR TO BELLAFILL DUE TO A PRIOR EYE-LID SURGERY ON BOTH EYES, SO THAT IS ANOTHER FACTOR TO CONSIDER IN EVALUATING THE PATIENT'S CURRENT CONDITION. SHE ALSO STATES THERE WAS NO SIGN OF INFECTION, NO REDNESS, NO PAIN, NO INFLAMMATION, NO WARMTH, AND NO NODULE.
09/11/17 UPDATES: SUNEVA RECEIVED ADDITIONAL INFORMATION OF ANOTHER BELLAFILL LOT NUMBER RELATED TO THIS PATIENT: LOT F161059. INJECTOR (DR. (B)(6)) STATES THAT LOT F161059 WAS INJECTED ON (B)(6) 2017 AFTER DEVELOPMENT OF THE PATIENT'S UNDER-EYE ISSUE. THIS LOT (F161059; EXPIRATION DATE 10/04/2017) WAS NOT INJECTED UNDER THE EYES, BUT WAS INJECTED IN THE NLF/MARIONETTES AREAS AND NOT IN THE AREA REPORTED BY DR. (B)(6) WITH THE BIOFILM INFECTION. SUNEVA CONDUCTED A REVIEW OF THIS LOT. NO ISSUES WERE FOUND. THE LOT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND MET ACCEPTANCE CRITERIA AT TIME OF PRODUCT RELEASE. NO ISSUES WERE NOTED WITH RETAINED LOT SAMPLES. ADVERSE EVENT TERM WAS COMPLETED. THIS WAS NOT AN ACTIVE FIELD AT THE TIME THIS EMDR WAS ORIGINALLY SUBMITTED. PREVIOUSLY PROVIDED INFO: ORIGINALLY SUBMITTED 07/07/2017. RE-SUBMITTED PER HELPDESK - SAME INFO THROUGHOUT. PATIENT (B)(6) WAS INJECTED OFF-LABEL UNDER THE EYES WITH BELLAFILL BY DR. (B)(6) ON TWO OCCASIONS: (B)(6) 2016 WITH ONE SYRINGE OF LOT F151124, MANUFACTURE DATE: 11/06/2015, EXP DATE: 02/21/2017. (B)(6) 2016 WITH ONE SYRINGE OF LOT F151024, MANUFACTURE DATE: 03/16/2015, EXP DATE: 07/29/2016. SUNEVA CONDUCTED A REVIEW OF BOTH LOTS. NO ISSUES WERE FOUND. THE LOT WAS MANUFACTURED IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND MET ACCEPTANCE CRITERIA AT TIME OF PRODUCT RELEASE. THE LOTS HAD SINCE EXPIRED THEREFORE RETAINED SAMPLES WERE NOT AVAILABLE FOR REVIEW. ON (B)(6) 2017, DR. (B)(6) RELAYED THAT HE SUSPECTS THE PATIENT'S SWELLING IS DUE TO A BIOFILM INFECTION THAT WAS INTRODUCED DURING THE PATIENT'S BELLAFILL INJECTIONS AND IS CAUSED BY STAPH EPI. HE BELIEVES THAT IT WILL RESOLVE OVER TIME, BUT WILL NOT RESOLVE WITHOUT TREATMENT (CURRENTLY ANTIBIOTICS AND PREDNISONE). HE STATES THERE IS NOTHING TO BIOPSY TO CONFIRM BIOFILM. HIS SUSPICION IS DUE TO THE PATIENT'S DOCUMENTED PERSISTENCE OF EDEMA. PER DR. (B)(6), INJECTOR, THE PATIENT HAS MALAR EDEMA WHICH WAS UNMASKED BY IRRITATION (IN THIS CASE, THE BELLAFILL INJECTION) AND STATES THAT THE EDEMA DUE TO THIS CONDITION TYPICALLY RESOLVES ON ITS OWN OVER TIME. PER DR. (B)(6), THE EDEMA IS 2CM ABOVE WHERE HE PLACED THE BELLAFILL. THE PATIENT WAS INJECTED UNDER THE EYES WHICH IS AN OFF-LABEL LOCATION. THE BELLAFILL INJECTOR (DR. (B)(6)) IS AWARE OF BELLAFILL INDICATIONS FOR USE. INJECTOR CONTACT INFO: (B)(6). THE PATIENT SAW ANOTHER DOCTOR, DR. (B)(6), AROUND (B)(6) 2017, WHO RECENTLY CALLED SUNEVA STATING THAT SHE IS NOT CONVINCED THIS IS BELLAFILL-RELATED. THE PATIENT'S STARTING ANATOMY HAD BEEN CHANGED PRIOR TO BELLAFILL DUE TO A PRIOR EYE-LID SURGERY ON BOTH EYES, SO THAT IS ANOTHER FACTOR TO CONSIDER IN EVALUATING THE PATIENT'S CURRENT CONDITION. SHE ALSO STATES THERE WAS NO SIGN OF INFECTION, NO REDNESS, NO PAIN, NO INFLAMMATION, NO WARMTH, AND NO NODULE.
PATIENT HAS UNDER EYE SWELLING AFTER BELLAFILL INJECTION. THE SUBSEQUENT TREATING DOCTOR (DR. (B)(6) BELIEVES THE PATIENT HAS A BIOFILM INFECTION CAUSED BY STAPH EPI INTRODUCED DURING BELLAFILL INJECTION AND REQUIRES TREATMENT TO RESOLVE. PATIENT (B)(6) WAS INJECTED OFF-LABEL UNDER THE EYES WITH BELLAFILL BY DR.(B(6) ON TWO OCCASIONS: (B)(6) 2016 WITH ONE SYRINGE OF LOT F151124. (B)(6) 2016 WITH ONE SYRINGE OF LOT F151024. ON (B)(6) 2017, DR. (B)(6) RELAYED THAT HE SUSPECTS THE PATIENT'S SWELLING IS DUE TO A BIOFILM INFECTION THAT WAS INTRODUCED DURING THE PATIENT'S BELLAFILL INJECTIONS AND IS CAUSED BY STAPH EPI. HE BELIEVES THAT IT WILL RESOLVE OVER TIME, BUT WILL NOT RESOLVE WITHOUT TREATMENT (CURRENTLY ANTIBIOTICS AND PREDNISONE). HE STATES THERE IS NOTHING TO BIOPSY TO CONFIRM BIOFILM. HIS SUSPICION IS DUE TO THE PATIENT'S DOCUMENTED PERSISTENCE OF EDEMA.
PATIENT HAS UNDER EYE SWELLING AFTER BELLAFILL INJECTION. THE SUBSEQUENT TREATING DOCTOR (DR. (B)(6)) BELIEVES THE PATIENT HAS A BIOFILM INFECTION CAUSED BY STAPH EPI INTRODUCED DURING BELLAFILL INJECTION AND REQUIRES TREATMENT TO RESOLVE. PATIENT (B)(6) WAS INJECTED OFF-LABEL UNDER THE EYES WITH BELLAFILL BY DR. (B)(6) ON TWO OCCASIONS: (B)(6) 2016 WITH ONE SYRINGE OF LOT F151124 (B)(6) 2016 WITH ONE SYRINGE OF LOT F151024. ON (B)(6) 2017, DR. (B)(6) RELAYED THAT HE SUSPECTS THE PATIENT'S SWELLING IS DUE TO A BIOFILM INFECTION THAT WAS INTRODUCED DURING THE PATIENT'S BELLAFILL INJECTIONS AND IS CAUSED BY STAPH EPI. HE BELIEVES THAT IT WILL RESOLVE OVER TIME, BUT WILL NOT RESOLVE WITHOUT TREATMENT (CURRENTLY ANTIBIOTICS AND PREDNISONE). HE STATES THERE IS NOTHING TO BIOPSY TO CONFIRM BIOFILM. HIS SUSPICION IS DUE TO THE PATIENT'S DOCUMENTED PERSISTENCE OF EDEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483179 | BELLAFILL DERMAL FILLER | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | SUNEVA MEDICAL, INC. | GBF0508 | F151124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |