MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALGISITE M 15X20CM CTN 10; DRESSING,WOUND,HYDROPHILIC

Model Number 59480300

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

Patient Problem Skin Burning Sensation (4540)

Event Date 03/12/2021

Event Type  Injury  

Event Description

It was reported that a private nurse applied an algisite m 15cm x 20cm dressing to a patient.The dressing was to be applied for 2 days but the patient removed the dressing herself as she had burning sensations.She used a convatec aquacel extra dressing instead.The patient was allergic to iodine.The instructions state: do not use on patients with a known allergy to any of the components.The nurse wants to know if the dressing contains iodine.The allergy stopped as soon as the dressing was removed.

Manufacturer Narrative

The device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.The probable root cause is the patient has had a reaction to the materials used within the dressing which include iodine.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to the reported event.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains no similar instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

H10: the device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.The probable root cause is the patient has had a reaction to the materials used within the dressing.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to the reported event.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains no similar instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALGISITE M 15X20CM CTN 10
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11684619
• MDR Text Key: 245980025
• Report Number: 8043484-2021-00870
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 05000223425241
• UDI-Public: 05000223425241
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59480300
• Device Catalogue Number: 66000521
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention