MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REMOVE WIPES CTN 50; SOLVENT, ADHESIVE TAPE

Catalog Number 59403125

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

Patient Problem Burn(s) (1757)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a burn occurred on an (b)(6) baby as a result of using remove wipes in combination with electrodes (with gel) (cardinal health kendall neonatal ecg electrodes).They stopped using the wipes, but it is unknown how the burn was treated.

Manufacturer Narrative

H10: additional information the product was not returned for evaluation, images were provided, clearly showing the burn experienced confirming the reported event.Medical review concluded, a procedural variance cannot be ruled out as a contributing factor to the reported event, which does not represent a device malfunction.One photo was provided that confirms the report.Based on the limited information provided, after a one time use the remove wipe was discontinued, however, it is unknown how the burn was treated.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant clinical information be provided, this complaint will be re-assessed.No further medical assessment is warranted at this time.The instruction for use explicitly states, 'warning: flammable.Avoid using near flames or sources of ignition i.E.Electrocautery procedures.' a documentation review has been conducted, confirming no manufacturing defects, complaint history has recorded previous occurrences of this nature and no historical actions have been observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device met manufacturing specifications upon release for distribution and continue to monitor for adverse trends relating to this product range.This investigation is now complete, confirming the event is not related to a manufacturing problem and that no corrective actions are deemed necessary.

• Brand Name: REMOVE WIPES CTN 50
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; austin, TX 78735 ; 5123913905
• MDR Report Key: 11382727
• MDR Text Key: 233731761
• Report Number: 8043484-2021-00403
• Device Sequence Number: 1
• Product Code: KOX
• UDI-Device Identifier: 40565120294
• UDI-Public: 40565120294
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 1252
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male