ABDOMINAL BINDER * A131056

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-09 for ABDOMINAL BINDER * A131056 manufactured by Deroyal Industries, Inc..

Event Text Entries

[3651749] Abdominal binder caused itching and rash. Rash light pink without blisters. Rash was all over the area where binder was touching skin. This facility has had more than 7 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. 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 who have and who have not had exposure to the same brand of skin prep as the patients on the other 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 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

MAUDE Entry Details

• Report Number: 3225962
• MDR Report Key: 3225962
• Date Received: 2013-07-09
• Date of Report: 2013-07-09
• Date of Event: 2013-07-05
• Report Date: 2013-07-09
• Date Reported to FDA: 2013-07-09
• Date Reported to Mfgr: 2013-07-15
• Date Added to Maude: 2013-07-15
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ABDOMINAL BINDER
• Generic Name: BINDER, ABDOMINAL
• Product Code: FSD
• Date Received: 2013-07-09
• Model Number: *
• Catalog Number: A131056
• Lot Number: 31622021
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEROYAL INDUSTRIES, INC.
• Manufacturer Address: 200 DEBUSK LANE POWELL TN 37849 US 37849

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-09