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  • Report:  #145074

Complaint Review: Bard Canada - Endoscopic Technologies

Bard - Endoscopic Technologies RIPOFF! Bard Button Replacement Gastrostomy device LEAKS, won't refund & they continue to sell defective product. Mississauga Canada

  • Reported By:
    Sutton Ontario
  • Submitted:
    Sat, June 04, 2005
  • Updated:
    Sat, June 11, 2005
  • Bard Canada - Endoscopic Technologies
    2345 Stanfield Rd
    Mississauga, Ontario
    Canada
  • Phone:
    800-826-BARD
  • Category:

Bard is the maker of the Bard Button Replacement Gastrostomy device - a silicone low-profile device made for insertion into an established stoma tract for long-term gastrostomy feeding.

I am a long-time user of the Bard button since 1997 and have had no problem until my latest bard button purchase/insertion: My new one leaks from the valve, even though the safety cap is in place. I have been since informed that a number of other patients are also experiencing this problem and no one has had any luck in dealing with this company which seems to have a policy of denial & illogical blame-shifting, and no policy of customer satisfaction. And they continue to sell the product defective.

Damages from leaking Bard buttons include:

- cost of a replacement gastrostomy device (~$300)
- medical establishment costs to replace device
- medical professional fees to replace device
- cost of acid-reducing medications to prevent skin-damage from leakage
- medical side-effects of these acid-reducing medications
- cost of clothing damaged from soiling.

When I place my old Bard button next to my new one, a design alteration is visible and this change is very simply and logically the cause of the leakage.

Bard will make ridiculous claims that any leakage is caused by incorrect use/procedures of the button, or possible damage done during insertion by the medical professionals. And they even say they have never received any complaints about this before! I hear some patients have sent their removed buttons back to Bard for them to inspect but the company has only come back with more denial.

If noone has yet sued this company, then it's probably only because users are patients who are ill and thus focused on other problems - and the reality is many have since passed away.

I am in Canada but I found reference to a New Zealand website that mentions Bard button leakage as being the number one reason patients have them removed.

Ada
Sutton, Ontario
Canada

2 Updates & Rebuttals


Ada

Sutton,
Ontario,
Canada

response

#3Consumer Comment

Sat, June 11, 2005

This gov't agency aims to ensure safety in medical devices, but will not help one get a refund, etc. If anyone out there has experienced the same problem (in Canada), they too can fill out and submit a voluntary Medical Devices Problem Report form.

The form can be found in
http://www.hc-sc.gc.ca/hpfb/inspectorate/rep_md_prob-rap_prob_im_tc_e.html

And the Guidance Document to aid in filling out the fields and that indicates where to mail/fax the form is in
http://www.hc-sc.gc.ca/hpfb/inspectorate/man_vol_pro_rep_md_e.pdf


Robert

Rochester,
New York,
U.S.A.

the government agency in Canada that regulates medical devices

#3Consumer Comment

Sun, June 05, 2005

Ada... if you are having problems with a medical device you can contact

Device Surveillance Division of the
Medical Devices Bureau, at (613) 954-028

This is the government agency in Canada that regulates medical devices.

This PDF file http://dsp-psd.communication.gc.ca/Collection/H12-39-1-1E.pdf

lists all of the phone numbers you can call.

Hope it helps.

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