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 2014-07-15 for ABDOMINAL BINDER * A131056 manufactured by Deroyal Industries Inc.

Event Text Entries

[4577048] Patient developed itchy localized raised red rash on back and abdomen requiring treatment with hydrocortizone cream bid and benadryl po as needed. This facility has had ongoing issues with this device over the last year. Rashes have developed after the abdominal binder is placed. Patients in all areas of the facility where the product is used have been affected. There is no apparent visual defect to the device. The rash develops within 24 hours after placement on the patient. Affected patients are not allergic to latex and have no previously reported allergies. Some patients have required medical intervention for the rash. The manufacturer has been notified and product has been returned. Contributing factors for the rash have not been able to be determined. The devices are stored in temperature controlled environments and are sealed in their individual packages until needed. Multiple lot numbers are involved. ======================manufacturer response for abdominal binder 9 in small/ medium, (brand not provided) (per site reporter). ======================notified deroyal representative and he plans to pick up for investigation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3937335
• MDR Report Key: 3937335
• Date Received: 2014-07-15
• Date of Report: 2014-07-15
• Date of Event: 2014-07-05
• Report Date: 2014-07-15
• Date Reported to FDA: 2014-07-15
• Date Reported to Mfgr: 2014-07-16
• Date Added to Maude: 2014-07-16
• 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: ABDOMINAL BINDER
• Product Code: FSD
• Date Received: 2014-07-15
• Model Number: *
• Catalog Number: A131056
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 DA
• 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		2014-07-15