BELKYRA SKIN GRID

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-13 for BELKYRA SKIN GRID manufactured by Allergan (irvine).

Event Text Entries

[89359547] Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of swelling, redness, pain, malaise, unable to sleep and (b)(6) infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling for belkyra? : warnings and precautions. For topical use only. Do not inject through the transferred grid markings. Do no use on broken or damaged skin.
Patient Sequence No: 1, Text Type: N, H10


[89359548] Healthcare professional reported injecting a patient with belkyra using the skin grid to the submental fat region. Patient developed swelling after the injection and 18 days later had swelling beyond normal expectations with redness and pain. The patient had malaise and was unable to sleep after the injection. The swollen area was aspirated and the patient was commenced on cephalexin. Three days later, the patient had another aspiration and commenced on dicloxacillin. After the belkyra had been drained, the healthcare professional noticed lymphocytes in the area which indicated an infection. A culture of the aspiration showed heavy growth of (b)(6). Patient symptoms are improving.
Patient Sequence No: 1, Text Type: D, B5


[96491682] The events necrotic tissue, abscess and dimpling/induration are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Patient Sequence No: 1, Text Type: N, H10


[96491683] Additional information: injection area was prepped with chlorhexidine 0. 05% antiseptic resolution prior to injection. Patient was advised to use cold compress for short periods after the injection and to keep the area clean and hydrated. Patient was free from any infection/inflammation prior to injection. Patient had developed a delayed abscess within the necrotic tissue of the submental fat which required antibiotics therapy and aspiration of significant swelling. Patient has had multiple reviews since treatment was provided and ongoing support. Patient still has a small submental abscess and related dimpling/induration of the skin. Symptoms are ongoing and patient continues to take oral antibiotics. Patient may be left with permanent scarring in the area and an undesirable cosmetic outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024601-2017-00009
MDR Report Key6949513
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-10-13
Date of Report2017-11-06
Date of Event2017-09-01
Date Mfgr Received2017-11-02
Date Added to Maude2017-10-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SUZANNE WOJCIK
Manufacturer Street301 W HOWARD LANE SUITE 100
Manufacturer CityAUSTIN TX 78753
Manufacturer CountryUS
Manufacturer Postal78753
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (IRVINE)
Manufacturer Street2525 DUPONT DRIVE
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal Code92612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBELKYRA SKIN GRID
Generic NameMARKER, SKIN
Product CodeFZZ
Date Received2017-10-13
Catalog NumberBELKYRA SKIN GRID
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (IRVINE)
Manufacturer Address2525 DUPONT DRIVE IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2017-10-13

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