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	Erythema (1840); Itching Sensation (1943); Blister (4537); Skin Burning Sensation (4540)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference case (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during an iv fixation treatment, the patient developed well-defined erythema, miliary papules, and scattered small blisters on the skin around the catheter placement, accompanied by obvious itching and burning sensation.This adverse event was treated by removing the dressing from one (1) iv3000 1 hand 10x12cm ctn 50 immediately according to the doctor's advice.Cleaned the affected area with physiological saline, wait for it to dry, applied 1ml x 2 doses of dexamethasone hydrochloride injection and took oral antihistamines for symptomatic treatment, then covered with a low sensitivity gauze dressing.After 3 days, the patient's discomfort symptoms gradually improved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).New information was provided by the reporter.Sections b5 and h6 were updated.
Event or Problem Description
It was reported that, during an iv fixation treatment, the patient developed well-defined erythema, miliary papules, and scattered small blisters on the skin around the catheter placement, accompanied by obvious itching and burning sensation.This event was noticed 24 hours after applying the dressing.This adverse event was treated by removing the dressing from one (1) iv3000 1 hand 10x12cm ctn 50 immediately according to the doctor's advice.Cleaned the affected area with physiological saline, wait for it to dry, applied 1ml x 2 doses of dexamethasone hydrochloride injection and took oral antihistamines for symptomatic treatment, then covered with a low sensitivity gauze dressing.After 3 days, the patient's discomfort symptoms gradually improved.

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23995795
• Report Number: 8043484-2026-00001
• Device Sequence Number: 18774317
• Product Code: KGX
• UDI-Device Identifier: 05000223040086
• UDI-Public: 5000223040086
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: 202501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2025
• 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
• Patient Age: 49 YR
• Patient Sex: Female