FDA.reportPublic FDA data

MAUDE MDR 7545662

MDR report key
7545662
Report number
2024601-2018-00007
Event key
0
Event type
3
Date of event
2017-11-15
Date received
2018-05-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SUZANNE WOJCIK
Address
301 W HOWARD LANE SUITE 100 AUSTIN TX 78753 US
Phone
737-737-7372
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KYBELLA SKIN GRIDMARKER, SKINALLERGAN (IRVINE)FZZKYBELLA SKIN GRIDNIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-2501. R

Event Narratives#

N

Patient 1

FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENTS OF ?DERMAL NECROSIS-TWO LESIONS, EACH MEASURING 1.5-2CM? ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: INJECTION TECHNIQUE THE SAFE AND EFFECTIVE USE OF KYBELLA? DEPENDS ON THE USE OF THE CORRECT NUMBER AND LOCATIONS FOR INJECTIONS, PROPER NEEDLE PLACEMENT, AND ADMINISTRATION TECHNIQUES. HEALTHCARE PROFESSIONALS ADMINISTERING KYBELLA? MUST UNDERSTAND THE RELEVANT SUBMENTAL ANATOMY AND ASSOCIATED NEUROMUSCULAR STRUCTURES IN THE AREA INVOLVED AND ANY ALTERATIONS TO THE ANATOMY DUE TO PRIOR SURGICAL OR AESTHETIC PROCEDURES [SEE WARNINGS AND PRECAUTIONS (5)]. AVOID INJECTIONS NEAR THE AREA OF THE MARGINAL MANDIBULAR NERVE [SEE WARNINGS AND PRECAUTIONS (5.1)] NEEDLE PLACEMENT WITH RESPECT TO THE MANDIBLE IS VERY IMPORTANT AS IT REDUCES THE POTENTIAL FOR INJURY TO THE MARGINAL MANDIBULAR NERVE, A MOTOR BRANCH OF THE FACIAL NERVE. INJURY TO THE NERVE PRESENTS AS AN ASYMMETRICAL SMILE DUE TO PARESIS OF LIP DEPRESSOR MUSCLES [SEE WARNINGS AND PRECAUTIONS (5.1)]. TO AVOID INJURY TO THE MARGINAL MANDIBULAR NERVE: DO NOT INJECT ABOVE THE INFERIOR BORDER OF THE MANDIBLE. DO NOT INJECT WITHIN A REGION DEFINED BY A 1-1.5 CM LINE BELOW THE INFERIOR BORDER (FROM THE ANGLE OF THE MANDIBLE TO THE MENTUM). INJECT KYBELLA? ONLY WITHIN THE TARGET SUBMENTAL FAT TREATMENT AREA (SEE FIGURES 1 AND AVOID INJECTION INTO THE PLATYSMA PRIOR TO EACH TREATMENT SESSION, PALPATE THE SUBMENTAL AREA TO ENSURE SUFFICIENT SUBMENTAL FAT AND TO IDENTIFY SUBCUTANEOUS FAT BETWEEN THE DERMIS AND PLATYSMA (PRE-PLATYSMAL FAT) WITHIN THE TARGET TREATMENT AREA (FIGURE 2). THE NUMBER OF INJECTIONS AND THE NUMBER OF TREATMENTS SHOULD BE TAILORED TO THE INDIVIDUAL PATIENT?S SUBMENTAL FAT DISTRIBUTION AND TREATMENT GOALS. INJECTION SITE ULCERATION AND NECROSIS: INJECTIONS THAT ARE TOO SUPERFICIAL (INTO THE DERMIS) MAY RESULT IN SKIN ULCERATION AND NECROSIS [SEE INJECTION TECHNIQUE (2.3)]. CASES OF INJECTION SITE ULCERATION AND NECROSIS HAVE BEEN REPORTED WITH THE ADMINISTRATION OF KYBELLA?. DO NOT ADMINISTER KYBELLA? INTO THE AFFECTED AREA UNTIL COMPLETE RESOLUTION OF THE ADVERSE REACTION.

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED THAT KYBELLA? WAS ADMINISTERED AND APPROXIMATELY 5 MONTHS LATER THE PATIENT EXPERIENCED DERMAL NECROSIS-TWO LESIONS. DOSE REGIMEN WAS 5.6CC, SINGLE, ROUTE OF ADMINISTRATION, WAS SUBCUTANEOUS IN THE SUBMENTAL REGION. THE KYBELLA? SKIN GRID WAS USED. SUPERFICIAL INJECTION WAS NOT INTENTIONALLY ATTEMPTED. IMMEDIATELY AFTER INJECTION THE PATIENT DEVELOPED LESIONS THAT PROGRESSIVELY GOT WORSE AND THE PATIENT DEVELOPED NECROSIS. HEALTHCARE PROFESSIONAL REPORTED THAT THERE WERE TWO LESIONS IN THE TREATMENT AREA, EACH MEASURING 1.5-2CM. THE AFFECTED AREA HAD TO BE EXCISED AND THE PATIENT WAS PROVIDED LASER TREATMENTS TO REDUCE SCARRING BUT IT WAS REPORTED THAT IT WAS STILL VERY EVIDENT AS THE PATIENT WAS NOT A GOOD HEALER. THE PATIENT DID NOT HAVE ANY SYSTEMIC SYMPTOMS. THE REPORTER WAS UNSURE IF THERE WAS ANY DYSPIGMENTATION AS THE PATIENT WAS STILL HEALING AND WAS LIKELY TO REQUIRE MULTIPLE PROCEDURES. AT THE TIME OF THE REPORTING THE OUTCOME OF THE EVENT WAS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.