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

Model Number	59403125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that a burn occurred on a (b)(6) as a result of using remove wipes in combination with electrodes (with gel) (cardinalhealth kendall neonatal ecg electrodes).The wipes were only used one time when the reaction occurred.It is unknown how the burn was treated but the wipes stopped being used directly.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: 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 reported event or determine a root cause.Probable root causes are the materials used within the dressing.Our medical assessment concluded: based on the complaint details, which report the use of the wipes in combination with electrodes, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Although it was communicated, after a one time use the remove wipe was discontinued, 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.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.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 harm.This investigation is now complete with no further action deemed necessary.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 50
• Common Device Name: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11389517
• Report Number: 8043484-2021-00404
• Device Sequence Number: 17079509
• Product Code: KOX
• UDI-Device Identifier: 00040565120287
• UDI-Public: 00040565120287
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 59403125
• Device Catalogue Number: 59403125
• Device Lot Number: 1252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 02/27/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 2 YR