MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REMOVE WIPES CTN 20X50; SOLVENT, ADHESIVE TAPE

Catalog Number 59403125

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

Patient Problem Skin Irritation (2076)

Event Date 06/22/2020

Event Type  Injury  

Event Description

We have a patient who received a nephrostomy this year.She has developed an eczema under the dressing that hold the tube caused by the remove wipes.Multiple patch tests were performed on the patient who had a reaction to several chemical components and to the remove wipes.Reaction was not treated but the health care unit stopped using the remove wipes and the reaction started to recover.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The product, intended for use in treatment, was not received for evaluation.We have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.If a complaint sample becomes available, the complaint will be reevaluated.Manufacturing batch records and packing batch records were reviewed, there were no anomalies noted which would contribute to this complaint.The product met all specifications upon release into distribution.A three-year complaint history review was completed and no other complaints have been received associated with this failure mode.Our clinical evaluation concluded: after multiple patch tests, this case document a patient with reactions to several chemical components, in addition to the removed wipes.Therefore, it is uncertain if the reaction patient experienced is due to an allergy to the remove wipes or the result of a non-allergic irritation caused by one or more chemicals used concurrently.The provided photo confirms the reported skin irritation; however, based on the limited information provided, its root cause cannot be determined.Per subsequent email, the treatment discontinued with the removal of the barrier-forming product.Per report: ¿the area under the dressing has recovered remarkably and is almost normal.¿ therefore, no further clinical assessment is warranted at this time.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: REMOVE WIPES CTN 20X50
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10279859
• MDR Text Key: 199041875
• Report Number: 8043484-2020-02043
• Device Sequence Number: 1
• Product Code: KOX
• UDI-Device Identifier: 40565120294
• UDI-Public: 40565120294
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 59403125
• Device Lot Number: 8557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention