MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. REMOVE 8.0 OZ BOTTLE 01; SOLVENT, ADHESIVE TAPE

Model Number	403300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during wound treatment, one patient experienced burns when using remove.It is used the adhesive remover, chlorhexidine, then chloraprep, and the burn is on the side of the patient where this might have pooled.A pad that circulates heated water to help with body temperature during the heart surgery is also laid.It is unknown how this event has been addressed.Patient outcome is also unknown.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, all supplied information has been reviewed and we have not been able to confirm the complaint.Medical review conclude, the complaint details, represents a procedure complication and does not represent a device malfunction.It is unknown if the direction for use of the remove 8.0 oz bottle 01 was adhered to.The remove is flammable use in a well-ventilated area.Wash the patient¿s skin with soap, water and then pat dry.¿ according to the report, this event was addressed by wound care consult.However, since this issue was unresolved, the impact to the patient beyond that which already been reported is unknown.Should any additional relevant patient information be provided, this complaint would be re-assessed.A probable root cause may included patients sensitivity to the product.A documentation review has been conducted, confirming no previous complaints of this nature and no historical escalations have been observed.A review of the device history confirmed that no manufacturing problems where 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.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: REMOVE 8.0 OZ BOTTLE 01
• 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
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12972106
• Report Number: 8043484-2021-02006
• Device Sequence Number: 4442995
• Product Code: KOX
• UDI-Device Identifier: 00040565112435
• UDI-Public: 00040565112435
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 403300
• Device Catalogue Number: 403300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown