MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4008
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Discomfort (2330)
Date of Event	02/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, when the patient was given sedation medication (mometasone) for acute gastroenteritis after completing venous puncture with an indwelling needle, a iv3000 1 hand 10x12cm ctn 50 was applied to prevent the needle from falling off.The patient experienced local itching and discomfort about 15 minutes after applying the dressing and a maculopapular rash was found at the dressing covered area after removing the dressing on his own.The patient was advised to be given a topical application of mometasone and the rash disappeared in about 1 hour.On the second day, the patient returned to the clinic again, and there was no obvious local rash or itching.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
It was reported that, when the patient was given sedation medication for acute gastroenteritis after completing venous puncture with an indwelling needle, a iv3000 1 hand 10x12cm ctn 50 was applied to prevent the needle from falling off.The patient experienced local itching and discomfort about 15 minutes after applying the dressing and a maculopapular rash was found at the dressing covered area after removing the dressing on his own.The patient was advised to be given a topical application of mometasone and the rash disappeared in about 1 hour.On the second day, the patient returned to the clinic again, and there was no obvious local rash or itching.
Additional Manufacturer Narrative
The device was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a definitive root cause.Probable root causes include allergic reaction by the patient to one of the components of the dressing, an existing skin disorder or incorrect application of the dressing or incorrect skin preparation.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.The complaint history review confirms a small number of similar complaints with no manufacturing problems observed.The ifu was reviewed.The precautions part of ifu instructed that 'as with all adhesive products, apply and remove carefully from sensitive or fragile skin.If reddening or sensitisation occurs, discontinue use'.A review of prior escalation actions found no actions applicable to the scope of this case.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.Per report, this patient experienced local itching and discomfort about 15 minutes after applying the iv3000 hand dressing and a maculopapular rash was found at the dressing covered area after removing the dressing on his own.However, the information provided is insufficient to determine whether the patient¿s maculopapular rash was due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the s+n iv3000, one or more of its components, or its intended therapeutic action.According to the report, the patient removed the dressing and was treated with a topical application of mometasone, and the rash disappeared within one hour.It was reported the next day the patient did not show any signs of the rash or itching.The impact to the patient was the itching, discomfort, rash, and medication.Should any additional relevant medical information be provided, this case would be re-assessed.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• 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: 19142430
• Report Number: 8043484-2024-00038
• Device Sequence Number: 7920713
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2024

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 Expiration Date: 12/01/2024
• Device Catalogue Number: 4008
• Device Lot Number: 202152
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/21/2024; 05/17/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 04/24/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOMETASONE WAS GIVEN FOR RASH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown