RESTYLANE INJECTABLE GEL
Report
- Report Number
- 2032896-2010-00015
- Event Type
- Other
- Date Received
- April 30, 2010
- Date of Event
- March 1, 2010
- Report Date
- April 29, 2010
- Manufacturer
- Q-MED AB
- Product Code
- LMH
- PMA / PMN Number
- P040024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADD'L PMA #: P020023.
ON (B)(6) 2010, A SPONTANEOUS REPORT BY A PHYSICIAN WAS REC'D FROM A COMPANY REP REGARDING A (B)(6), FEMALE, WHO REC'D AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MED HISTORY INCLUDED PSORIASIS OF THE SCALP, PREVIOUS INJECTION OF BOTOX (ONABOTULINUMTOXINA) TO THE GLABELLAR AREA ON AN UNSPECIFIED DATE IN (B)(6) 2009 AND NO PREVIOUS INJECTIONS TO THE GLABELLAR AREA OTHER THAN BOTOX; THE PT WAS OTHERWISE HEALTHY. THE PT'S SKIN TYPE WAS NOT REPORTED. THE PT REC'D AN INJECTION OF RESTYLANE (AMOUNT INJECTED REPORTED AS UNK) ON AN UNSPECIFIED DATE IN (B)(6) 2010 (REPORTED AS "SOMETIME IN (B)(6) 2010") TO THE GLABELLAR LINE (ALSO REPORTED AS "JUST A FINE LITTLE STRING" WAS INJECTED, JUST ENOUGH TO FILL THE GLABELLAR LINE). NO PRE-PROCEDURE MEDICATION WAS GIVEN. ADD'L PROCEDURES AT THE TIME OF IMPLANTATION INCLUDED BOTOX TO THE GLABELLAR LINE. ON AN UNSPECIFIED DATE IN (B)(6) 2010, AFTER THE IMPLANTATION, THE PT DEVELOPED SWELLING AND A PAINFUL PLAQUE AT THE GLABELLAR INJECTION SITE. THE PT WAS PRESCRIBED DOXYCYCLINE 100 MG TWICE DAILY (REPORTED AS "BID") ON AN UNSPECIFIED DATE IN (B)(6) 2010. AFTER STARTING TREATMENT WITH DOXYCYCLINE, THE PT INITIALLY REPORTED SHE WAS BETTER, THEREFORE, THE DOXYCYCLINE WAS CONTINUED. THE PT THEN HAD A WORSENING OF SWELLING AND PAIN TO THE AREA. ON (B)(6) 2010, THE PT WAS EVALUATED BY A DERMATOLOGIST, NOT THE INJECTING PHYSICIAN, WHO PERFORMED A BIOPSY OF THE GLABELLAR PLAQUE. THE RESULTS OF THE BIOPSY SHOWED REFRACTILE FOREIGN BODY CRYSTALS. THE CRYSTALS WERE NOT SILICONE, BUT WERE SILICONE-LIKE (ALSO REPORTED BY THE COMPANY REP AS "THERE WAS NO HA IN THERE, BUT IT DID HAVE BI-REFRACTILE CRYSTALS/SILICON"). ON (B)(6) 2010, THE DERMATOLOGIST ALSO PERFORMED AN INCISION AND DRAINAGE OF THE AREA, HOWEVER, NO DRAINAGE WAS NOTED. ACID-FAST BACILLUS (AFB), ATYPICAL MYCOBACTERIA, FUNGUS AND BACTERIAL CULTURES WERE PERFORMED. THE INCISION WAS THEN PARTIALLY SUTURED AND THE WOUND WAS FULLY PACKED. THE DOXYCYCLINE WAS DISCONTINUED AND NO ADD'L MEDICATIONS WERE PRESCRIBED, AS THE DERMATOLOGIST WANTED TO WAIT FOR THE CULTURE RESULTS BEFORE PRESCRIBING ANY ADD'L MEDICATION. ON (B)(6) 2010, ADD'L INFO WAS REC'D FROM THE DERMATOLOGIST WHO REPORTED THAT THE CULTURE RESULTS WERE NEGATIVE "TO THIS DATE." THE DERMATOLOGIST REPORTED THAT THE PT WAS EVALUATED ON (B)(6) 2010. THE PT HAD REMOVED THE PACKING. ANOTHER INCISION AND DRAINAGE WAS PERFORMED DURING WHICH PUS WAS DRAINED. THE AREA WAS RE-CULTURED FOR AFB, ATYPICAL MYCOBACTERIA, FUNGUS AND BACTERIA AND THE WOUND WAS RE-PACKED. THE DERMATOLOGIST PLANNED TO WAIT TO TREAT THE PT ANY FURTHER UNTIL THE CULTURE RESULTS FROM (B)(6) 2010, WERE OBTAINED. AS OF (B)(6) 2010, NO DIAGNOSIS HAD BEEN ESTABLISHED FOR THE PT'S SYMPTOMS AND THE PT CONTINUED TO HAVE SWELLING AND PAIN IN THE GLABELLAR AREA. THE PT WAS TO BE SEEN BY THE DERMATOLOGIST AGAIN FOR FOLLOW-UP ON (B)(6) 2010. THE DERMATOLOGIST REPORTED HE HAD "NO IDEA" IF RESTYLANE HAD CAUSED THE REPORTED EVENTS. THE DERMATOLOGIST ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE WERE 9863 AND 09/2011, RESPECTIVELY. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTYLANE INJECTABLE GEL | INJECTABLE DERMAL FILLER | LMH | Q-MED AB | NA | 9863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | VITAMIN D| AN UNSPECIFIED MULTIVITAMIN| "OMEGA 3S"| CLOBETASON PROPIONATE SOLUTION| CRANBERRY "PILLS" |