[3575281]
Per mother baby nurse: "velcro binder causing itchy red flattish rash where binder covered on abdomen". Rash was nonraised. Binder was removed and replaced with soft stretchy binder (different product). This facility has had more than 9 similar events with this product in the last 5 months. Product states latex free. The facility reports this type of reaction has been seen in patients with c-sections as well as vaginal deliveries; thus, staff does not believe that there is a reaction to the skin prep used for c-section deliveries because the prep is not used in a vaginal delivery. Also, staff has stated in previous incidents that the rash occurs on areas which does not have the skin prep but does have contact with the binder. Patients with and without known allergies have been affected. The manufacturer has been notified. They are unaware of any other complaints like this. We checked with our surgical unit because they use quite a few abdominal binders and they have not heard of any concerns regarding rash. Patients in the surgical unit would have similar use of this device. Also, there are patients in the surgical unit both who have and who have not had exposure to the same brand of skin prep as the patients on the other nursing unit. The storage procedure/process for both nursing units is identical: storage and transportation of the devices are not believed to be contributing factors in these events. ======================manufacturer response for medium/large abdominal binder, (brand not provided) (per site reporter). ======================spoke with deroyal rep. They plan to send shipping label for product return. Below is an email from deroyal senior area manager that was sent to the manager of materials management:"i have people checking into any problems with these ab binders. But as of now i have heard of no problems at other accounts using these two products. They are used at (xxx), (xx) and (x) hospital. That being said if you would like to try a different binder that is still on contract i would try. 13661056 9in s/m13662067 9in m/lo&m may have these in stock since they are used in some (hospital) accounts. If not we can drop ship them for o&m. Hope this helps. Deroyal orthopedics senior area manager"what was the original intended procedure? S/p c-section. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5