MAUDE Adverse Event Report: CONVATEC, INC DUODERM SIGNAL 20X22.5CM; DRESSING,WOUND,OCCLUSIVE

Model Number 410508

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)

Event Date 06/15/2014

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

The nurse reported the duoderm signal dressing on the patient's sacrum needed to be changed many times during the day (5 times in 4 hours) due to a lack of stickiness.It was further reported that the frequent dressing changes resulted in skin irritation.Additionally, the nurse indicated that some patients are allergic to the product so they can't change it every 2 hours.The patient was treated with an unspecified cream.It was reported that the dressing was used only while the patient was in the hospital.

• Brand Name: DUODERM SIGNAL 20X22.5CM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC, INC; 211 american ave; greensboro 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5124320
• MDR Text Key: 27364005
• Report Number: 1049092-2015-30219
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/30/2017
• Device Model Number: 410508
• Device Lot Number: 4C02467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1