RESTYLANE
Report
- Report Number
- 9710154-2023-00020
- Event Type
- Injury
- Date Received
- April 6, 2023
- Date of Event
- March 27, 2023
- Report Date
- June 22, 2023
- Manufacturer
- Q-MED AB
- Product Code
- LMH
- PMA / PMN Number
- P040024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
COMPANY COMMENT: THE SERIOUS EVENTS OF SWELLING AND HYPERSENSITIVITY WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS AND OVERNIGHT HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES THE PATIENT'S HYPERSENSITIVITY TO THE PRODUCTS. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND INDICATE A POSSIBLE INVOLVEMENT OF THE PRODUCT. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE CURRENTLY PERFORMED INVESTIGATIONS.
COMPANY COMMENT: THE SERIOUS EVENTS OF OEDEMA AND HYPERSENSITIVITY AND THE NON-SERIOUS EVENT OF MASS AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS AND OVERNIGHT HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES THE PATIENT'S HYPERSENSITIVITY TO THE PRODUCTS. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND INDICATE A POSSIBLE INVOLVEMENT OF THE PRODUCT. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA QUALITY MANAGEMENT SYSTEM. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.
COMPANY COMMENT: THE SERIOUS EVENTS OF SWELLING AND HYPERSENSITIVITY AND THE NON-SERIOUS EVENT OF MASS AT IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS AND OVERNIGHT HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES THE PATIENT'S HYPERSENSITIVITY TO THE PRODUCTS. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. PRODUCT NOTE: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND INDICATE A POSSIBLE INVOLVEMENT OF THE PRODUCT. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. A BATCH RECORD REVIEW WILL BE PERFORMED TO EXCLUDE A NON-CONFORMING PRODUCT. RECOMMENDATION FOR CORRECTIVE AND PREVENTATIVE ACTION: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE CURRENTLY PERFORMED INVESTIGATIONS.
THE SERIOUS EVENTS OF SWELLING AND HYPERSENSITIVITY WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENTS. SERIOUSNESS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS AND OVERNIGHT HOSPITALIZATION TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES THE PATIENT'S HYPERSENSITIVITY TO THE PRODUCTS. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND INDICATE A POSSIBLE INVOLVEMENT OF THE PRODUCT. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 28-MAR-2023 BY A DENTAL SURGEON WHICH REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION OR HISTORY OF ALLERGIES HAS BEEN PROVIDED. THE PATIENT HAD NEVER RECEIVED ANY AESTHETIC INJECTABLE AND THIS WAS THE FIRST TIME. ON (B)(6) 2023 (AROUND 4:30 PM), THE PATIENT RECEIVED TREATMENT WITH 0.8 ML OF RESTYLANE (LOT 20324-1) TO THE LIP AND 0.8 ML OF RESTYLANE LYFT (LOT 20421-1) TO THE CHIN WITH UNKNOWN INJECTION TECHNIQUE AND NEEDLE TYPE. ON (B)(6) 2023, APPROXIMATELY 20 MINUTES AFTER THE INJECTION, THE PATIENT EXPERIENCED AN ALLERGIC REACTION (HYPERSENSITIVITY) AND SHE WAS VERY SWOLLEN/EDEMA (OEDEMA), HER MOUTH SWELLED BUT CHIN DID NOT. THE REPORTER INFORMED THAT THE PATIENT DID NOT EXPERIENCE PAIN AT THE OFFICE. ON (B)(6) 2023, THE PATIENT RECEIVED CORRECTIVE TREATMENT WITH METICORTEN [PREDNISONE] 20 MG EVERY 12 HOURS AT 07:52 PM AND ALLEGRA [FEXOFENADINE HYDROCHLORIDE] 180 MG 1 PER DAY AT 09:22 PM AT HER HOME. THE PHYSICIAN REPORTED THAT PATIENT WAS TREATED WITH UNSPECIFIED ANTI-INFLAMMATORY AND AN ANALGESIC, BUT THE SWELLING DID NOT RESOLVE. AS THERE WAS NO IMPROVEMENT, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2023 AT 10:20 PM AND REQUIRED HOSPITALIZATION. SHE RECEIVED TREATMENT WITH ADRENALINE [EPINEPHRINE], SOLUMEDROL [METHYLPREDNISOLONE SODIUM SUCCINATE] AND BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] AT THE HOSPITAL. ON (B)(6) 2023, AT 05:00 AM, THE PATIENT RECEIVED TREATMENT WITH FENERGAN [PROMETHAZINE HYDROCHLORIDE]. ACCORDING TO THE REPORTER, THE PHYSICIANS WHO ACCOMPANIED THE PATIENT IN THE HOSPITAL ADVISED THAT SHE SHOULD REMOVE THE PRODUCT, OTHERWISE SHE WOULD NOT GET BETTER. ON (B)(6) 2023 (AROUND 08:00 AM), THE PATIENT WAS DISCHARGED WITH THE PRESCRIPTION OF PREDNISONE [PREDNISONE] 20 MG, 02 CAPSULES IN THE MORNING FOR 5 DAYS AND HIXIZINE [HYDROXYZINE HYDROCHLORIDE] EVERY 8 HOURS FOR 7 DAYS. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL VERY SWOLLEN, AND THE MEDICATIONS ONLY HELPED HER FROM GETTING WORSE. THE PATIENT WAS ORIENTED BY PHYSICIAN ABOUT REMOVAL WITH HYALURONIDASE AND DERMATOLOGIST'S TREATMENT. ACCORDING TO THE PATIENT, THE EDEMA STARTED TO REDUCE WHEN SHE WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, THE REPORTING HCP WAS WAITING FOR THE PATIENT BECAUSE THE PATIENT WOULD LIKE TO RECEIVE TREATMENT WITH HYALURONIDASE. AFTER 24 HOURS FROM EVENT ONSET, THE PATIENT WAS NO LONGER SWOLLEN AND EXPERIENCED A WRINKLED SKIN ON THE FACE THAT RESOLVED WITH A MASSAGE AND A LITTLE SMALL BALL (IMPLANT SITE MASS) REMAINED ON FACE. THE EVENTS WERE CLASSIFIED AS MODERATE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT TREATMENT WITH HYALURONIDASE [HYALURONIDASE] WAS NOT PERFORMED ONCE EVENTS DISAPPEARED. ON (B)(6) 2023, THE REPORTING HCP HAD FORWARDED THREE PHOTOS OF THE PATIENT'S EDEMA. BASED ON THE PHOTOS, THE REPORTER INFORMED THAT THE FILLER HAD NOT BEEN REMOVED. LATER, THE PATIENT WAS REFERRED TO A DERMATOLOGIST WHO APPLIED HYALURONIC ACID AND HYALURONIDASE TO VERIFY IF SHE HAD AN ALLERGIC REACTION AS PER PICTURE OF PATIENT'S ARM. THE PATIENT DID NOT WANT TO REMOVE THE HYALURONIC ACID AS IT WAS JUST AN EDEMA INFORMED BY THE REPORTER. CURRENTLY, THE PATIENT WAS WELL AND WITHOUT NEW EPISODE. OUTCOME AT THE TIME OF THE REPORT: ALLERGIC REACTION WAS RECOVERED/RESOLVED. SWOLLEN/EDEMA WAS RECOVERED/RESOLVED. LITTLE SMALL BALL WAS NOT RECOVERED/NOT RESOLVED/ONGOING. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 05-MAY-2023 FROM THE SAME REPORTER: REPORTER TYPE UPDATED TO PHYSICIAN. EVENT OF IMPLANT SITE MASS ADDED. SEVERITY OF EVENTS, OUTCOME AND CORRECTIVE TREATMENT DETAILS WERE UPDATED. V.2 FU RECEIVED ON 18-MAY-2023 FROM THE SAME REPORTER. VERBATIM AND CODING OF THE EVENT SWELLING UPDATED TO OEDEMA. EVENT LOCATION UPDATED. INFORMATION ABOUT PREVIOUS AESTHETIC TREATMENT, REFERRAL TO DERMATOLOGIST WAS PROVIDED.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2023 BY A DENTAL SURGEON WHICH REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION OR HISTORY OF ALLERGIES HAS BEEN PROVIDED. THE PATIENT HAD NEVER RECEIVED ANY AESTHETIC INJECTABLE AND THIS WAS THE FIRST TIME. ON (B)(6) 2023 (AROUND 4:30 PM), THE PATIENT RECEIVED TREATMENT WITH 0.8 ML OF RESTYLANE (LOT 20324-1) TO THE LIP AND 0.8 ML OF RESTYLANE LYFT (LOT 20421-1) TO THE CHIN WITH UNKNOWN INJECTION TECHNIQUE AND NEEDLE TYPE. ON (B)(6) 2023, APPROXIMATELY 20 MINUTES AFTER THE INJECTION, THE PATIENT EXPERIENCED AN ALLERGIC REACTION (HYPERSENSITIVITY) AND SHE WAS VERY SWOLLEN/EDEMA (OEDEMA), HER MOUTH SWELLED BUT CHIN DID NOT. THE REPORTER INFORMED THAT THE PATIENT DID NOT EXPERIENCE PAIN AT THE OFFICE. ON (B)(6) 2023, THE PATIENT RECEIVED CORRECTIVE TREATMENT WITH METICORTEN [PREDNISONE] 20 MG EVERY 12 HOURS AT 07:52 PM AND ALLEGRA [FEXOFENADINE HYDROCHLORIDE] 180 MG 1 PER DAY AT 09:22 PM AT HER HOME. THE PHYSICIAN REPORTED THAT PATIENT WAS TREATED WITH UNSPECIFIED ANTI-INFLAMMATORY AND AN ANALGESIC, BUT THE SWELLING DID NOT RESOLVE. AS THERE WAS NO IMPROVEMENT, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2023 AT 10:20 PM AND REQUIRED HOSPITALIZATION. SHE RECEIVED TREATMENT WITH ADRENALINE [EPINEPHRINE], SOLUMEDROL [METHYLPREDNISOLONE SODIUM SUCCINATE] AND BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] AT THE HOSPITAL. ON (B)(6) 2023, AT 05:00 AM, THE PATIENT RECEIVED TREATMENT WITH FENERGAN [PROMETHAZINE HYDROCHLORIDE]. ACCORDING TO THE REPORTER, THE PHYSICIANS WHO ACCOMPANIED THE PATIENT IN THE HOSPITAL ADVISED THAT SHE SHOULD REMOVE THE PRODUCT, OTHERWISE SHE WOULD NOT GET BETTER. ON (B)(6) 2023 (AROUND 08:00 AM), THE PATIENT WAS DISCHARGED WITH THE PRESCRIPTION OF PREDNISONE [PREDNISONE] 20 MG, 02 CAPSULES IN THE MORNING FOR 5 DAYS AND HIXIZINE [HYDROXYZINE HYDROCHLORIDE] EVERY 8 HOURS FOR 7 DAYS. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL VERY SWOLLEN, AND THE MEDICATIONS ONLY HELPED HER FROM GETTING WORSE. THE PATIENT WAS ORIENTED BY PHYSICIAN ABOUT REMOVAL WITH HYALURONIDASE AND DERMATOLOGIST'S TREATMENT. ACCORDING TO THE PATIENT, THE EDEMA STARTED TO REDUCE WHEN SHE WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, THE REPORTING HCP WAS WAITING FOR THE PATIENT BECAUSE THE PATIENT WOULD LIKE TO RECEIVE TREATMENT WITH HYALURONIDASE. AFTER 24 HOURS FROM EVENT ONSET, THE PATIENT WAS NO LONGER SWOLLEN AND EXPERIENCED A WRINKLED SKIN ON THE FACE THAT RESOLVED WITH A MASSAGE AND A LITTLE SMALL BALL (IMPLANT SITE MASS) REMAINED ON FACE. THE EVENTS WERE CLASSIFIED AS MODERATE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT TREATMENT WITH HYALURONIDASE [HYALURONIDASE] WAS NOT PERFORMED ONCE EVENTS DISAPPEARED. ON (B)(6) 2023, THE REPORTING HCP HAD FORWARDED THREE PHOTOS OF THE PATIENT'S EDEMA. BASED ON THE PHOTOS, THE REPORTER INFORMED THAT THE FILLER HAD NOT BEEN REMOVED. LATER, THE PATIENT WAS REFERRED TO A DERMATOLOGIST WHO APPLIED HYALURONIC ACID AND HYALURONIDASE TO VERIFY IF SHE HAD AN ALLERGIC REACTION AS PER PICTURE OF PATIENT'S ARM. THE PATIENT DID NOT WANT TO REMOVE THE HYALURONIC ACID AS IT WAS JUST AN EDEMA INFORMED BY THE REPORTER. CURRENTLY, THE PATIENT WAS WELL AND WITHOUT NEW EPISODE. OUTCOME AT THE TIME OF THE REPORT: ALLERGIC REACTION WAS RECOVERED/RESOLVED. SWOLLEN/EDEMA WAS RECOVERED/RESOLVED. LITTLE SMALL BALL WAS NOT RECOVERED/NOT RESOLVED/ONGOING. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON (B)(6) 2023 FROM THE SAME REPORTER: REPORTER TYPE UPDATED TO PHYSICIAN. EVENT OF IMPLANT SITE MASS ADDED. SEVERITY OF EVENTS, OUTCOME AND CORRECTIVE TREATMENT DETAILS WERE UPDATED. V.2 FU RECEIVED ON (B)(6) 2023 FROM THE SAME REPORTER. VERBATIM AND CODING OF THE EVENT SWELLING UPDATED TO OEDEMA. EVENT LOCATION UPDATED. INFORMATION ABOUT PREVIOUS AESTHETIC TREATMENT, REFERRAL TO DERMATOLOGIST WAS PROVIDED. V.3 BRR RESULTS RECEIVED ON (B)(6)2023.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 28-MAR-2023 BY A PHYSICIAN WHICH REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2023 (AROUND 4:30 PM), THE PATIENT RECEIVED TREATMENT WITH 0.8 ML OF RESTYLANE (LOT 20324-1) TO THE LIP AND 0.8 ML OF RESTYLANE LYFT (LOT 20421-1) TO THE CHIN WITH UNKNOWN INJECTION TECHNIQUE AND NEEDLE TYPE. ON (B)(6) 2023, APPROXIMATELY 20 MINUTES AFTER THE INJECTION, THE PATIENT EXPERIENCED AN ALLERGIC REACTION (HYPERSENSITIVITY) AND SHE WAS VERY SWOLLEN (SWELLING), HER MOUTH SWELLED BUT CHIN DID NOT. THE REPORTER INFORMED THAT THE PATIENT DID NOT EXPERIENCE PAIN AT THE OFFICE. ON (B)(6) 2023, THE PATIENT RECEIVED CORRECTIVE TREATMENT WITH METICORTEN [PREDNISONE] 20 MG EVERY 12 HOURS AT 07:52 PM AND ALLEGRA [FEXOFENADINE HYDROCHLORIDE] 180 MG 1 PER DAY AT 09:22 PM AT HER HOME. THE PHYSICIAN REPORTED THAT PATIENT WAS TREATED WITH UNSPECIFIED ANTI-INFLAMMATORY AND AN ANALGESIC, BUT THE SWELLING DID NOT RESOLVE. AS THERE WAS NO IMPROVEMENT, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2023 AT 10:20 PM AND REQUIRED HOSPITALIZATION. SHE RECEIVED TREATMENT WITH ADRENALINE [EPINEPHRINE], SOLUMEDROL [METHYLPREDNISOLONE SODIUM SUCCINATE] AND BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] AT THE HOSPITAL. ON (B)(6) 2023, AT 05:00 AM, THE PATIENT RECEIVED TREATMENT WITH FENERGAN [PROMETHAZINE HYDROCHLORIDE]. ACCORDING TO THE REPORTER, THE PHYSICIANS WHO ACCOMPANIED THE PATIENT IN THE HOSPITAL ADVISED THAT SHE SHOULD REMOVE THE PRODUCT, OTHERWISE SHE WOULD NOT GET BETTER. ON (B)(6) 2023 (AROUND 08:00 AM), THE PATIENT WAS DISCHARGED WITH THE PRESCRIPTION OF PREDNISONE [PREDNISONE] 20 MG, 02 CAPSULES IN THE MORNING FOR 5 DAYS AND HIXIZINE [HYDROXYZINE HYDROCHLORIDE] EVERY 8 HOURS FOR 7 DAYS. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL VERY SWOLLEN, AND THE MEDICATIONS ONLY HELPED HER FROM GETTING WORSE. THE PATIENT WAS ORIENTED BY PHYSICIAN ABOUT REMOVAL WITH HYALURONIDASE AND DERMATOLOGIST'S TREATMENT. ON (B)(6) 2023, THE REPORTING HCP WAS WAITING FOR THE PATIENT BECAUSE THE PATIENT WOULD LIKE TO RECEIVE TREATMENT WITH HYALURONIDASE. AFTER 24 HOURS FROM EVENT ONSET, THE PATIENT WAS NO LONGER SWOLLEN AND EXPERIENCED A WRINKLED SKIN ON THE FACE THAT RESOLVED WITH A MASSAGE AND A LITTLE SMALL BALL (IMPLANT SITE MASS) REMAINED ON FACE. THE EVENTS WERE CLASSIFIED AS MODERATE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT TREATMENT WITH HYALURONIDASE [HYALURONIDASE] WAS NOT PERFORMED ONCE EVENTS DISAPPEARED. OUTCOME AT THE TIME OF THE REPORT: ALLERGIC REACTION WAS RECOVERED/RESOLVED. SWOLLEN WAS RECOVERED/RESOLVED. LITTLE SMALL BALL WAS NOT RECOVERED/NOT RESOLVED/ONGOING. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 05-MAY-2023 FROM THE SAME REPORTER: REPORTER TYPE UPDATED TO PHYSICIAN. EVENT OF IMPLANT SITE MASS ADDED. SEVERITY OF EVENTS, OUTCOME AND CORRECTIVE TREATMENT DETAILS WERE UPDATED.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2023 BY A DENTIST WHICH REFERS TO A FEMALE PATIENT OF AN UNKNOWN AGE. NO INFORMATION ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2023 (AROUND 4:30 PM), THE PATIENT RECEIVED TREATMENT WITH 0.8 ML OF RESTYLANE (LOT 20324-1) TO THE LIP AND 0.8 ML OF RESTYLANE LYFT (LOT 20421-1) TO THE CHIN WITH UNKNOWN INJECTION TECHNIQUE AND NEEDLE TYPE. ON (B)(6) 2023, JUST 20 MINUTES AFTER THE INJECTION, THE PATIENT HAD EXPERIENCED AN ALLERGIC REACTION (HYPERSENSITIVITY) AND SHE WAS VERY SWOLLEN (SWELLING), HER MOUTH SWELLED BUT CHIN DID NOT. THE REPORTER INFORMED THAT THE PATIENT DID NOT EXPERIENCE PAIN AT THE OFFICE. ON (B)(6) 2023, THE PATIENT RECEIVED CORRECTIVE TREATMENT WITH METICORTEN [PREDNISONE] 20 MG EVERY 12 HOURS AT 07:52 PM AND ALLEGRA [FEXOFENADINE HYDROCHLORIDE] 180 MG 1 PER DAY AT 09:22 PM AT HER HOME. AS THERE WAS NO IMPROVEMENT, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2023 AT 10:20 PM AND REQUIRED HOSPITALIZATION. SHE RECEIVED TREATMENT WITH ADRENALINE [EPINEPHRINE], SOLUMEDROL [METHYLPREDNISOLONE SODIUM SUCCINATE] AND BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] AT HOSPITAL. ON (B)(6) 2023, AT 05:00 AM, THE PATIENT RECEIVED TREATMENT WITH FENERGAN [PROMETHAZINE HYDROCHLORIDE]. ACCORDING TO THE REPORTER, THE PHYSICIANS WHO ACCOMPANIED THE PATIENT IN THE HOSPITAL ADVISED THAT SHE SHOULD REMOVE THE PRODUCT, OTHERWISE SHE WOULD NOT GET BETTER. ON (B)(6) 2023 (AROUND 08:00 AM), THE PATIENT WAS DISCHARGED WITH THE PRESCRIPTION OF PREDNISONE [PREDNISONE] 20 MG, 02 CAPSULES IN THE MORNING FOR 5 DAYS AND HIXIZINE [HYDROXYZINE HYDROCHLORIDE] EVERY 8 HOURS FOR 7 DAYS. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL VERY SWOLLEN, AND THE MEDICATIONS ONLY HELPED HER FROM GETTING WORSE. ON (B)(6) 2023, THE REPORTING HCP WAS WAITING FOR THE PATIENT BECAUSE THE PATIENT WOULD LIKE TO RECEIVE TREATMENT WITH HYALURONIDASE. OUTCOME AT THE TIME OF THE REPORT: ALLERGIC REACTION WAS UNKNOWN. SWOLLEN WAS NOT RECOVERED/NOT RESOLVED/ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1869617 | RESTYLANE | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | Q-MED AB | 20324-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H |