Bimini Health Tech Complaint Form

*Required for product replacements.

** Ideal Implant Structured Breast Implant is now the Puregraft Serene Breast Implant.
Bimini Health Tech Complaint Form

PUREGRAFT | HEALEON | DERMAPOSE
Please Only One Device Lot/Serial Number/Other Issue Per Complaint Form
Healthcare Provider Information
NAME of Physician / Technician who had incident or is Explanting Implant. *
(Please do not include patient information)
TITLE of Physician / Technician*
NAME of Hospital or Clinic for Incident or Implant Explantation*
ADDRESS of Hospital or Clinic(Full, including country) *
PHONE NUMBER of Hospital or Clinic*

Country CodeArea CodePhone Number
EMAIL of Hospital or Clinic*
example@example.com
Person Completing This Form / Key Contact

If different than Physician / Technician above.
Person Completing Form*
What is your relation to this product complaint?
Distributor Company Name
Reporting Person Name
Reporter's Title
Phone Number

Country CodeArea CodePhone Number
Email
example@example.com

Incident Details
Date of Incident*

MonthDayYear
Patient Name

First NameLast Name
Patient Date of Birth

MonthDayYear
Date
Complaint Category (Implant)
Complaint Category (PRP Gel Tubes)
Complaint Category (Puregraft 50/250/850)
Please describe, in as much detail as possible, the failure / incident*
Please do not include any Protected Health Information (PHI) in this description. (i.e. names, identifying numbers, geographic areas more specific than states, etc.)
Was death or serious injury caused by this incident?*

YesNo
Failed product(s) able to be returned for investigation?*

Yes, I can send upon Bimini's request.No, already disposed.Yes, this is a Breast Implant, I will call 1-858-348-8050 for free explant kit.No, product will continue to be used.
Date for Explant (planned or completed)

MonthDayYear
Please upload all photos and/or videos taken of the incident. These are very helpful and much appreciated.

Cancelof
Please verify that you are human*
Should be Empty:

Healthcare Provider Information