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(b)(6) outpatient surgical team applied a bandage to my back while i was sedated and instructed me to leave on 48 hours.I informed the surgical team (nurse who prepared me, anesthesiologist, doctor, technician) prior to the procedure that i am allergic to latex and adhesive (as well as a few other things), they cause itching.(b)(6) affixed this bandage to my back when i was under sedation.I did not know the bandage's makeup, properties, composition, type, nature, i trusted and relied on the outpatient surgical team to follow and adhere to my stated allergies (adhesive and latex) and that they would not affix anything to my back that i am allergic to and especially affix to my back for 48 hours, and especially on my back where i sleep on my back thereby mashing the adhesive (and also possibly latex as well if this bandage contains latex) more firmly, tightly, and strongly into my skin making it all the worse.I was not afforded, given, offered, or allowed any opportunity to provide informed consent to affix a bandage i am allergic to, to my back and to leave it affixed for 48 hours.I call this bandage "super adhesive" it took me approximately 15 minutes to remove the bandage as it was so firmly, tightly, and strongly attached.I did not want to rip it off therefore i had to gradually ease it off in little increments.The reason for the outpatient surgery is i have mast cell activation syndrome (mcas) where i am in a heightened allergic state 24/7, they think i have mastocytosis the more severe form of mcas, the only way to diagnose mastocytosis is via a bone marrow aspiration, therefore with my mcas and suspected mastocytosis all the more reason to adhere to my stated latex and adhesive allergies.When i removed the bandage at 48 hours intense localized itching at the bandage site on a scale of 1-10 it was 100, trouble breathing, heart racing.I went to the (b)(6) hospital's emergency room upon examination they said the skin at the bandage site was red and a rash, they prescribed hydroxyzine hcl (atarax) 25 mg tablets and hydrocortisone 1% topical cream (cortaid maximum strength).I brought the bandage with me to the emergency room to show everyone i dealt with and to tell them what happened, while there i called the charge nurse to meet me in the emergency room which he did to show him the bandage and to tell him what happened, no one in the emergency room including neither the charge nurse nor the emergency room doctor submitted fda form 3500.The bandage (b)(6) used is called curad flex fabric bandage.I am writing (b)(6) today for the exact name of the bandage, the brand, model number, catalog number, lot number, serial number, udi number, expiration date, when i get this information i will be submitting fda form 3500b.I wrote curad asking i want to know does curad make a bandage that is used in a hospital that has two components to it that i am looking for, what is the exact name of curad's same one hospital bandage that is both latex free as well as adhesive free.Please provide exact name of the hospital bandage that is both latex free as well as adhesive free, model number, catalog number, lot number, serial number, and udi number.With the information i have provided is (b)(6) hospital in violation of any fda rules or regs involving a medical device namely a bandage, they do not even know how to use a simple bandage.I had complained about all this by phone to (b)(6) hospital's patient relations representative and got a written response stating "what was put on your back and instructed to leave on 48 hours was gauze and tegaderm" neither was on my back when i went to remove at 48 hours".I responded in writing to this statement of (b)(6) hospital, based on my written response the patient relations representative set up a conference call with herself, me, and the supervisory nurse, this was who i believe provided the accounting to patient relations of gauze and tegaderm affixed to my back.The supervisory nurse was going around and around in the conference call, she kept glossing over things, i had to keep probing, i had to come right out and definitively confront her and pin her down point blank, i said "well if gauze and tegaderm wasn't put on my back then what was" she said "curad flex fabric bandage", to which i responded "then why is gauze and tegaderm stated in the letter", the supervisory nurse said "well they use gauze and tegaderm in the surgery suite", i responded "so they affixed something to my back that they don't use in the surgery suite" the supervisory nurse said "well they use both either gauze and tegaderm or curad flex fabric bandage", i then said "my medical records need to be corrected that gauze and tegaderm was not affixed to my back", the supervisory nurse said "gauze and tegaderm is not in your medical records".This was such a bizarre and weird conference call, entirely incompetent, negligent, unconcerned, and disinterested, i'm trying to tell and complain to (b)(6) hospital that they ignored my allergies and affixed a bandage to my back that i am allergic to.Also it was/is obviously imperative that i know what exactly and precisely was put on my back so as to alert doctors, hospitals, and labs.This medical device is not to be used on me or for when i purchase bandages at the drug store i don't unknowingly purchase this same bandage that i am allergic to.My emergency room symptoms of difficulty breathing and heart racing were short of anaphylaxis which could have been life threatening.(b)(6) hospital patient relations representative along with the conference call supervisory nurse, neither submitted an fda form 3500.I had informed everyone involved - the outpatient surgery team prior to the procedure, all personnel i encountered in the emergency room, the patient relations representative, and the conference call supervisory nurse that i have mast cell activation syndrome (mcas) and my doctors suspect i have the more severe form of mcas, mastocytosis that's why i was having bone marrow aspiration for mastocytosis diagnosis, all the more reason to adhere to my stated allergies.No one at (b)(6) hospital has/is taking this seriously or paying any attention to it, i believe sanctions are in order, can the fda levy sanctions against (b)(6) hospital.I had asked everyone i encountered in the emergency room (including the charge nurse and the doctor) when i showed them the bandage since it's their bandage, i would think they would know "does this bandage contain latex", no one knew or said they will find out or look into it.I did not ask if it contained adhesive as it was obvious it contained adhesive since it took me approximately 15 minutes to take the bandage off, when i had the conference call with the patient relations representative and the supervisory nurse i asked the supervisory nurse if the bandage contains latex she said it does not, i cannot rely on anything this supervisory nurse said as i believe she is the one who reported to the patient relations representative gauze and tegaderm was affixed to my back, the patient relations representative put gauze and tegaderm in her letter to me in response to my complaint, the supervisory nurse in the conference call admitted gauze and tegaderm is not in my medical records.When patient relations responds to my letter requesting the exact name of the bandage, brand, model number, catalog number, lot number, serial number, udi number, expiration date, i will be providing curad with this information asking if this bandage contains latex in either the adhesive and/or the non adhesive part if it also contains latex.In addition to adhesive that would make it all the worse (b)(6) hospital ignoring me stating "i'm allergic to adhesive and latex it causes itching" as well as making it all the worse with the supervisory nurse in the conference call stating it does not contain latex, i will be finding out.
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