RESTYLANE LIDOCAINE
Report
- Report Number
- 9710154-2018-00021
- Event Type
- Injury
- Date Received
- March 19, 2018
- Report Date
- April 19, 2018
- Manufacturer
- GALDERMA Q-MED
- Product Code
- LMH
- PMA / PMN Number
- P040024/S039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4), VERSION 0 INITIAL REPORT. CAPA: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. MANUFACTURER NARRATIVE: NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA (B)(4) QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENTS OF ISCHEMIA, NECROSIS, AND ABSCESS AT THE IMPLANT SITES, AND THE NON-SERIOUS EVENTS OF DISCOLORATION, BRUISING, AND PAIN AT THE IMPLANT SITES WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THE NON-SERIOUS, UNEXPECTED EVENT OF PUSTULES AT THE IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED; THIS EVENT LIKELY RESULTED FROM THE ISCHEMIA AND NECROSIS. POTENTIAL CONTRIBUTORY FACTORS INCLUDE THE INJECTION TECHNIQUE AND THE PATIENT'S HISTORY OF CYSTIC ACNE WITH PURULENT DISCHARGE. SERIOUS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT A POTENTIAL PERMANENT DAMAGE TO BODY STRUCTURE INCLUDING STEROIDS, GENTAMICIN ANTIBIOTIC THERAPY, ABSCESS DRAINAGE AND TOPICAL BROMELIN ANTI-INFLAMMATORY, WOUND HEALING AGENT. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: THE DEVICE WAS NOT RETURNED TO SEND TO THE MANUFACTURER FOR EVALUATION. EXEMPTION: EXEMPTION: GALDERMA LABORATORIES L.P. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB (MANUFACTURER). EXEMPTION NUMBER E2015005
Q-MED AB (MANUFACTURER) REGISTRATION NUMBER:(B)(4). ARISG CASE NUMBER: (B)(4) FOLLOW UP REPORT CAPA: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. MANUFACTURER NARRATIVE: NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA UPPSALA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENTS OF ISCHEMIA, NECROSIS, AND ABSCESS AT THE IMPLANT SITES, AND THE NON-SERIOUS EVENTS OF DISCOLORATION, BRUISING, AND PAIN AT THE IMPLANT SITES WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THE NON-SERIOUS, UNEXPECTED EVENT OF PUSTULES AT THE IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED. POTENTIAL ETIOLOGIES FOR THE REPORTED EVENTS INCLUDE COMPLICATIONS FROM VASCULAR COMPROMISE THE AND THE UNDERLYING CYSTIC ACNE WITH PURULENT DISCHARGE. THE REPORTING PHYSICIAN ATTRIBUTED THE ABSCESS TO THE UNDERLYING ACNE RATHER THAN VASCULAR COMPROMISE. POTENTIAL CONTRIBUTORY "FACTORS" INCLUDE THE INJECTION TECHNIQUE. SERIOUS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT A POTENTIAL PERMANENT DAMAGE TO BODY STRUCTURE INCLUDING STEROIDS, GENTAMICIN ANTIBIOTIC THERAPY, ABSCESS DRAINAGE AND TOPICAL BROMELIN ANTI-INFLAMMATORY, WOUND HEALING AGENT. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.
Q-MED AB (MANUFACTURER) REGISTRATION NUMBER: (B)(4). ARISG CASE NUMBER: (B)(4) FOLLOW UP REPORT. CAPA: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. MANUFACTURER NARRATIVE: NO POTENTIAL QUALITY ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING PROCESS OF THE SPECIFIED BATCH. THE BATCH IS MANUFACTURED AND RELEASED ACCORDING TO GALDERMA UPPSALA QUALITY MANAGEMENT SYSTEM. PHARMACOVIGILANCE COMMENT: THE SERIOUS EVENTS OF ISCHEMIA, NECROSIS, AND ABSCESS AT THE IMPLANT SITES, AND THE NON-SERIOUS EVENTS OF DISCOLORATION, BRUISING, AND PAIN AT THE IMPLANT SITES WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THE NON-SERIOUS, UNEXPECTED EVENT OF PUSTULES AT THE IMPLANT SITE WAS CONSIDERED POSSIBLY RELATED. POTENTIAL ETIOLOGIES FOR THE REPORTED EVENTS INCLUDE COMPLICATIONS FROM VASCULAR COMPROMISE THE AND THE UNDERLYING CYSTIC ACNE WITH PURULENT DISCHARGE. THE REPORTING PHYSICIAN ATTRIBUTED THE ABSCESS TO THE UNDERLYING ACNE RATHER THAN VASCULAR COMPROMISE. POTENTIAL CONTRIBUTORY FACTOS INCLUDE THE INJECTION TECHNIQUE. SERIOUS CRITERIA INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT A POTENTIAL PERMANENT DAMAGE TO BODY STRUCTURE INCLUDING STEROIDS, GENTAMICIN ANTIBIOTIC THERAPY, ABSCESS DRAINAGE AND TOPICAL BROMELIN ANTI-INFLAMMATORY, WOUND HEALING AGENT. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. ADDITIONAL COMMENTS: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. EXEMPTION NUMBER: E2015005. GALDERMA LABORATORIES, L.P. (IMPORTER REGISTRATION NUMBER: (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB (MANUFACTURER REGISTRATION NUMBER: (B)(4).
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 26-FEB-2018 BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED AROUND (B)(6) YEARS. ADDITIONAL INFORMATION WAS PROVIDED ON 27-FEB-2018. THE PATIENT'S MEDICAL HISTORY INCLUDED NODULOCYSTIC ACNE WITH RESIDUAL SCAR. MANY TREATMENT WERE PERFORMED IN ORDER TO TREAT ACNE AND TO IMPROVE SCARS (PEELING, PHYSICAL TREATMENT, POLYNUCLEOTIDES). THE REPORTER ALSO STATED THAT "THE PATIENT HAS LOST A LOT OF BODY WEIGHT IN A SHORT PERIOD OF TIME" CAUSING THE CHEEKBONES TO "FLOPP DOWN DUE TO SEVERE SLIMMING OF THE PATIENT". ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH RESTYLANE LYFT LIDOCAINE (LOT 14894, EXPIRATION DATE 2019-08-31) THAT WAS USED ON CHECKBONES AND 0.15 ML IN NASOLABIAL FOLDS, AND RESTYLANE LIDOCAINE 0.2 ML (LOT 15237, EXPIRATION DATE 2020-01-31) IN NASOLABIAL FOLDS WITH RETROGRADE-LINEAR TECHNIQUE AND IN THE OTHER SPECIFIED FACE AREAS. THE PHYSICIAN SPECIFIED THAT RESTYLANE LYFT LIDOCAINE WAS USED TO RAISE THE CHEEKBONES. RESTYLANE LIDOCAINE WAS INJECTED IN ORDER TO PAVE THE MANDIBULAR PROFILE OF THE LEFT NASOLABIAL FOLD. IMMEDIATELY AFTER THE INJECTIONS, THE PATIENT NOTED THE PRESENCE OF PURPLE-LIKE AREA (IMPLANT SITE DISCOLOURATION) IN THE LEFT NASOLABIAL FOLD. THIS AREA WAS EXTENDED TO THE UPPER LIP. IN THE FOLLOWING DAYS, THE PATIENT DEVELOPED ERYTHEMATOUS PUSTULES(IMPLANT SITE PUSTULES) IN THE UPPER PART OF THE LEFT NASOLABIAL FOLD. THE DIAGNOSIS OF TISSUE ISCHEMIA AND NECROSIS(IMPLANT SITE ISCHAEMIA)(IMPLANT SITE NECROSIS) WAS PERFORMED. THE REPORTING PHYSICIAN REVISED THE REPORT ON (B)(6) 2018 AND STATED "IMMEDIATELY AFTER THE INJECTIONS, THE PATIENT DEVELOPED A BRUISE ON ONE OF THE NOSE'S WING AND ON THE UPPER LIP THAT WAS DUE TO MOST LIKELY TO AN EXTRAVASATION. THE PHYSICIAN REPORTED THAT, DURING THE INJECTION, SHE CAUSED THE BRUISE DUE TO LESION TO BLOOD VESSEL(IMPLANT SITE BRUISING)." THE DAY AFTER THE INJECTIONS, THE PATIENT TOLD TO THE PHYSICIAN THAT THE BRUISE HAD DISAPPEARED. NINE DAYS AFTER THE INJECTIONS, THE PATIENT EXPERIENCED PAIN(IMPLANT SITE PAIN) AND SHE NOTED THE FORMATION OF AN ABSCESS (IMPLANT SITE ABSCESS) IN THE AREAS WHERE THE INJECTIONS WERE MADE. THE PATIENT CONTACTED THE PHYSICIAN, WHO DECIDED TO DRAIN THE PUS FROM THE ABSCESS, AND THEN TO TREAT THE PATIENT WITH CORTISONE-BASED DRUGS [CORTICOSTEROID NOS], GENTALYN BETA [BETAMETHASONE VALERATE][GENTAMICIN SULFATE] AND TOPICAL BROMELINE [BROMELAINS]. THE PHYSICIAN CONFIRMED THAT "ALL THESE EVENTS OCCURRED WERE NOT CAUSED BY THE HYALURONIC ACID ACCUMULATION AT THE SITES OF INJECTION BECAUSE SHE DID NOT FELT THE PRESENCE OF GRANULOMAS CONTAINING THE PRODUCT BY TOUCHING ANTEROLATERAL WALLS OF THE MOUTH. THE PRESENCE OF THE ABSCESS WAS NOT CAUSED BY THE WRONG USAGE OF THE MEDICAL DEVICE, BUT DUE TO THE CYSTIC ACNE AFFECTING THE PATIENT." OUTCOME AT THE TIME OF THE REPORT: BRUISE DUE TO LESION TO BLOOD VESSEL WAS RECOVERED/RESOLVED. OUTCOME FOR THE OTHER EVENTS WAS UNKNOWN.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 26-FEB-2018 BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED AROUND 40 YEARS. ADDITIONAL INFORMATION WAS PROVIDED ON 27-FEB-2018 AND 19-MAR-2018. THE PATIENT'S MEDICAL HISTORY INCLUDED NODULOCYSTIC ACNE WITH RESIDUAL SCAR. MANY TREATMENT WERE PERFORMED IN ORDER TO TREAT ACNE AND TO IMPROVE SCARS (PEELING, PHYSICAL TREATMENT, POLYNUCLEOTIDES). THE REPORTER ALSO STATED THAT "THE PATIENT HAS LOST A LOT OF BODY WEIGHT IN A SHORT PERIOD OF TIME" CAUSING THE CHEEKBONES TO "FLOPP DOWN DUE TO SEVERE SLIMMING OF THE PATIENT". ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH RESTYLANE LYFT LIDOCAINE (LOT 14894, EXPIRATION DATE 2019-08-31) THAT WAS USED ON "CHEEKBONES" AND 0.15 ML IN NASOLABIAL FOLDS, AND RESTYLANE LIDOCAINE 0.2 ML (LOT 15237, EXPIRATION DATE 2020-01-31) IN NASOLABIAL FOLDS WITH RETROGRADE-LINEAR TECHNIQUE AND IN THE OTHER SPECIFIED FACE AREAS. THE PHYSICIAN SPECIFIED THAT RESTYLANE LYFT LIDOCAINE WAS USED TO RAISE THE CHEEKBONES. RESTYLANE LIDOCAINE WAS INJECTED IN ORDER TO PAVE THE MANDIBULAR PROFILE OF THE LEFT NASOLABIAL FOLD. IMMEDIATELY AFTER THE INJECTIONS, THE PATIENT NOTED THE PRESENCE OF PURPLE-LIKE AREA(IMPLANT SITE DISCOLOURATION) IN THE LEFT NASOLABIAL FOLD. THIS AREA WAS EXTENDED TO THE UPPER LIP. IN THE FOLLOWING DAYS, THE PATIENT DEVELOPED ERYTHEMATOUS PUSTULES(IMPLANT SITE PUSTULES) IN THE UPPER PART OF THE LEFT NASOLABIAL FOLD. THE DIAGNOSIS OF TISSUE ISCHEMIA AND NECROSIS(IMPLANT SITE ISCHAEMIA)(IMPLANT SITE NECROSIS) WAS PERFORMED. THE REPORTING PHYSICIAN REVISED THE REPORT ON 27-FEB-2018 AND STATED "IMMEDIATELY AFTER THE INJECTIONS, THE PATIENT DEVELOPED A BRUISE ON ONE OF THE NOSE'S WING AND ON THE UPPER LIP THAT WAS DUE TO MOST LIKELY TO AN EXTRAVASATION. THE PHYSICIAN REPORTED THAT, DURING THE INJECTION, SHE CAUSED THE BRUISE DUE TO LESION TO BLOOD VESSEL(IMPLANT SITE BRUISING)." THE DAY AFTER THE INJECTIONS, THE PATIENT TOLD TO THE PHYSICIAN THAT THE BRUISE HAD DISAPPEARED. NINE DAYS AFTER THE INJECTIONS, THE PATIENT EXPERIENCED PAIN(IMPLANT SITE PAIN) AND SHE NOTED THE FORMATION OF AN ABSCESS(IMPLANT SITE ABSCESS) IN THE AREAS WHERE THE INJECTIONS WERE MADE. THE PATIENT CONTACTED THE PHYSICIAN, WHO DECIDED TO DRAIN THE PUS FROM THE ABSCESS, AND THEN TO TREAT THE PATIENT WITH CORTISONE-BASED DRUGS [CORTICOSTEROID NOS], GENTALYN BETA [BETAMETHASONE VALERATE][GENTAMICIN SULFATE] AND TOPICAL BROMELINE [BROMELAINS]. THE PHYSICIAN CONFIRMED THAT "ALL THESE EVENTS OCCURRED WERE NOT CAUSED BY THE HYALURONIC ACID ACCUMULATION AT THE SITES OF INJECTION BECAUSE SHE DID NOT FELT THE PRESENCE OF GRANULOMAS CONTAINING THE PRODUCT BY TOUCHING ANTEROLATERAL WALLS OF THE MOUTH. THE PRESENCE OF THE ABSCESS WAS NOT CAUSED BY THE WRONG USAGE OF THE MEDICAL DEVICE, BUT DUE TO THE CYSTIC ACNE AFFECTING THE PATIENT." FOLLOW UP INFORMATION RECEIVED ON 19-MAR-2018 FROM THE PHYSICIAN BY PHONE: THE PHYSICIAN STATED THAT THE PATIENT NOTED, IN THE AREA OF CHEEKBONE, THE PRESENCE OF AN ABSCESS. IN THE OPINION OF THE PHYSICIAN, THE TISSUE UNDER THE ABSCESS COULD BE OF SCAR-TYPE AND THIS COULD HAVE COMPROMISED THE CORRECT ABSORPTION OF THE PRODUCT ONCE INJECTED. HOWEVER, AS STATED BY THE PHYSICIAN, THIS IS NOT A CASE OF PRODUCT ACCUMULATION, BUT THE PRESENCE OF ABSCESS WAS DUE TO THE CONCOMITANT DISEASE OF THE PATIENT (EVIDENT CYSTIC ACNE WITH PURULENT ABSCESS). OUTCOME AT THE TIME OF THE REPORT: BRUISE DUE TO LESION TO BLOOD VESSEL WAS RECOVERED/RESOLVED. OUTCOME FOR THE OTHER EVENTS WAS UNKNOWN. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 19-MAR-2018 FROM THE PHYSICIAN.
CASE REFERENCE NUMBER: (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2018 BY A PHYSICIAN WHICH REFERS TO A FEMALE AGED AROUND 40 YEARS. ADDITIONAL INFORMATION WAS PROVIDED ON 27-FEB-2018, 19-MAR-2018, AND 10-APR-2018. THE PATIENT'S MEDICAL HISTORY INCLUDED NODULOCYSTIC ACNE WITH RESIDUAL SCAR. MANY TREATMENTS WERE PERFORMED IN ORDER TO TREAT ACNE AND TO IMPROVE SCARS (PEELING, PHYSICAL TREATMENT, POLYNUCLEOTIDES). THE REPORTER ALSO STATED THAT "THE PATIENT HAS LOST A LOT OF BODY WEIGHT IN A SHORT PERIOD OF TIME" CAUSING THE CHEEKBONES TO "FLOPP DOWN DUE TO SEVERE SLIMMING OF THE PATIENT". ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH RESTYLANE LYFT LIDOCAINE (LOT: 14894, EXPIRATION DATE 2019-08-31) THAT WAS USED ON CHECKBONES AND 0.15 ML IN NASOLABIAL FOLDS, AND RESTYLANE LIDOCAINE 0.2 ML (LOT: 15237, EXPIRATION DATE 2020-01-31) IN NASOLABIAL FOLDS WITH RETROGRADE-LINEAR TECHNIQUE AND IN THE OTHER SPECIFIED FACE AREAS. THE PHYSICIAN SPECIFIED THAT RESTYLANE LYFT LIDOCAINE WAS USED TO RAISE THE CHEEKBONES. RESTYLANE LIDOCAINE WAS INJECTED IN ORDER TO PAVE THE MANDIBULAR PROFILE OF THE LEFT NASOLABIAL FOLD. IMMEDIATELY AFTER THE INJECTIONS, THE PATIENT NOTED THE PRESENCE OF PURPLE-LIKE AREA(IMPLANT SITE DISCOLOURATION) IN THE LEFT NASOLABIAL FOLD. THIS AREA WAS EXTENDED TO THE UPPER LIP. IN THE FOLLOWING DAYS, THE PATIENT DEVELOPED ERYTHEMATOUS PUSTULES(IMPLANT SITE PUSTULES) IN THE UPPER PART OF THE LEFT NASOLABIAL FOLD. THE DIAGNOSIS OF TISSUE ISCHEMIA AND NECROSIS(IMPLANT SITE ISCHAEMIA) (IMPLANT SITE NECROSIS) WAS PROVIDED. THE REPORTING PHYSICIAN REVISED THE REPORT ON (B)(6) 2018 AND STATED "IMMEDIATELY AFTER THE INJECTIONS, THE PATIENT DEVELOPED A BRUISE ON ONE OF THE NOSE'S WING AND ON THE UPPER LIP THAT WAS MOST LIKELY DUE TO AN EXTRAVASATION". THE PHYSICIAN REPORTED THAT, DURING THE INJECTION, SHE CAUSED THE "BRUISE DUE TO LESION TO BLOOD VESSEL(IMPLANT SITE BRUISING)." THE DAY AFTER THE INJECTIONS, THE PATIENT TOLD TO THE PHYSICIAN THAT THE BRUISE HAD DISAPPEARED. NINE DAYS AFTER THE INJECTIONS, THE PATIENT EXPERIENCED PAIN (IMPLANT SITE PAIN) AND SHE NOTED THE FORMATION OF AN ABSCESS (IMPLANT SITE ABSCESS) IN THE AREAS WHERE THE INJECTIONS WERE MADE. THE PATIENT CONTACTED THE PHYSICIAN, WHO DECIDED TO DRAIN THE PUS FROM THE ABSCESS, AND THEN TO TREAT THE PATIENT WITH CORTISONE-BASED DRUGS [CORTICOSTEROID NOS], GENTALYN BETA [BETAMETHASONE VALERATE] [GENTAMICIN SULFATE] AND TOPICAL BROMELINE [BROMELAINS]. THE PHYSICIAN CONFIRMED THAT "ALL THESE EVENTS OCCURRED WERE NOT CAUSED BY THE HYALURONIC ACID ACCUMULATION AT THE SITES OF INJECTION BECAUSE SHE DID NOT FELT THE PRESENCE OF GRANULOMAS CONTAINING THE PRODUCT BY TOUCHING ANTEROLATERAL WALLS OF THE MOUTH. THE PRESENCE OF THE ABSCESS WAS NOT CAUSED BY THE WRONG USAGE OF THE MEDICAL DEVICE, BUT DUE TO THE CYSTIC ACNE AFFECTING THE PATIENT." FOLLOW UP INFORMATION RECEIVED ON B)(6) 2018 FROM THE PHYSICIAN BY PHONE: THE PHYSICIAN STATED THAT THE PATIENT NOTED, IN THE AREA OF CHEEKBONE, THE PRESENCE OF AN ABSCESS. IN THE OPINION OF THE PHYSICIAN, THE TISSUE UNDER THE ABSCESS COULD BE OF SCAR-TYPE AND THIS COULD HAVE COMPROMISED THE CORRECT ABSORPTION OF THE PRODUCT ONCE INJECTED. HOWEVER, AS STATED BY THE PHYSICIAN, THIS IS NOT A CASE OF PRODUCT ACCUMULATION, BUT THE PRESENCE OF ABSCESS WAS DUE TO THE CONCOMITANT DISEASE OF THE PATIENT (EVIDENT CYSTIC ACNE WITH PURULENT ABSCESS). FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2018 FROM THE PHYSICIAN BY PHONE: THE PHYSICIAN STATED THAT THE PATIENT WAS IN GOOD HEALTH CONDITIONS. THERE WAS NO DAMAGE REPORTED. IT WAS ONLY A TEMPORARY SKIN LESION THAT, ON UNKNOWN DATE, TOTALLY RESOLVED. OUTCOME AT THE TIME OF THE REPORT: THE EVENTS WERE RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL. V.1 FU RECEIVED ON (B)(6) 2018 FROM THE PHYSICIAN. V.2 FU RECEIVED ON (B)(6) 2018: PATIENT RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192940 | RESTYLANE LIDOCAINE | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | GALDERMA Q-MED | 15237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |