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,consum report with the FDA on 2019-01-16 for BELKYRA SKIN GRID manufactured by Allergan (irvine).

Event Text Entries

[133257581] 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 inflamed lymph nodes, abscess and infection 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


[133257582] Patient reported having been injected with belkyra. It is not known if the skin grid was used. Patient developed inflamed lymph nodes in the right lateral submandibular area 2 weeks after the injection. Patient then developed an abscess afterwards. It was noted that the infection was treated with antibiotics and drainage. Symptoms ongoing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024601-2019-00003
MDR Report Key8254091
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-01-16
Date of Report2019-01-16
Date Mfgr Received2018-12-20
Date Added to Maude2019-01-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 Received2019-01-16
Catalog NumberBELKYRA SKIN GRID
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-01-16

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