KELLER FUNNEL2 (1PK) HA-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-05 for KELLER FUNNEL2 (1PK) HA-001 manufactured by Allergan (keller).

Event Text Entries

[141051204] Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
Patient Sequence No: 1, Text Type: N, H10


[141051205] Healthcare professional reported "the doctor noticed the implant had a fracture and bubbles after insertion into the pocket using a keller funnel? ". One breast implant was affected by this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011299751-2019-00077
MDR Report Key8487216
Report SourceHEALTH PROFESSIONAL
Date Received2019-04-05
Date of Report2019-04-05
Date of Event2019-03-04
Date Mfgr Received2019-03-13
Date Added to Maude2019-04-05
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 ContactMRS. MICHELLE BURGESS
Manufacturer Street301 W HOWARD LANE SUITE 100
Manufacturer CityAUSTIN TX 78753
Manufacturer CountryUS
Manufacturer Postal78753
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (KELLER)
Manufacturer Street1239 SE INDIAN ST STE 112
Manufacturer CitySTUART FL 34997
Manufacturer CountryUS
Manufacturer Postal Code34997
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKELLER FUNNEL2 (1PK)
Generic NameKIT, SURGICAL INSTRUMENT, DISPOSABLE
Product CodeKDD
Date Received2019-04-05
Catalog NumberHA-001
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (KELLER)
Manufacturer Address1239 SE INDIAN ST STE 112 STUART FL 34997 US 34997


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-05

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