HULKA CLIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for HULKA CLIP manufactured by Richard Wolf.

Event Text Entries

[40211442] Subject: hulka clip recall message: my name is (b)(6) and i am (b)(6). I had a tubal ligation via the hulka clip per my doctor's choice. After many years of suffering and going back and forth to doctors as well as putting my family through hell, i find out that the hulka clips have been recalled in 2009 and 2014. So many women suffer on a daily basis from having a tubal ligation. There are several issues we've had yet nobody listens until it's too late. We aren't told the true side effects and therefore we can't truly give informed consent. With that being said where was the notification there had been a recall on these clips? Shouldn't the doctors that have used these clips on their patients have some sense of responsibility or does that fall to the manufacturer? I can tell you, the doctors are who i trusted and as a woman that had 12 years of her life stolen, someone should be held accountable for a faulty device that has been removed from the market! We have these dangerous clips inside of our bodies killing us and nobody cares, nobody listens! This is fraudulent and someone needs to be held accountable. Research for cancer is done on a daily basis, has anyone stopped to think it could come from the metal or chemicals being placed inside our body? The imbalances these devices cause within our bodies deserve proper medical attention. We need help just like a cancer patient or bipolar patient. Our lives matter and we deserve to be informed. (b)(6). A (b)(6) 2001 tubal ligation, (b)(6) 2013 fallopian tubes removed. Several dr appt's from 2001-2013 due to pelvic pains, abdominal pains, infections etc.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060833
MDR Report Key5495278
Date Received2016-03-08
Date of Report2016-03-08
Date Added to Maude2016-03-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHULKA CLIP
Generic NameHULKA CLIP
Product CodeHGB
Date Received2016-03-08
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRICHARD WOLF


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-08

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