MAUDE Adverse Event Report: DEROYAL INDUSTRIES INC ABDOMINAL BINDER

Catalog Number A131056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033)

Event Date 07/05/2014

Event Type  No Answer Provided  

Event Description

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.
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manufacturer response for abdominal binder 9 in small/ medium, (brand not provided) (per site reporter).
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notified deroyal representative and he plans to pick up for investigation.

• Brand Name: ABDOMINAL BINDER
• Type of Device: ABDOMINAL BINDER
• Manufacturer (Section D): DEROYAL INDUSTRIES INC; 200 debusk lane; powell TN 37849
• MDR Report Key: 3937335
• MDR Text Key: 4577048
• Report Number: 3937335
• Device Sequence Number: 1
• Product Code: FSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: A131056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2014
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 77