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

Catalog Number 4008

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Blister (4537)

Event Date 08/27/2020

Event Type  Injury  

Event Description

It was reported that 2 days later after transparent dressing used in the treatment of pico, itching and blisters was on the patient's skin.Therefore, the dressing was replaced.It was also necessary to wash with light salt water.

Manufacturer Narrative

Device evaluated by mfr: we have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with these failure modes in the past three years.A risk management review was carried out.The risk files for this product contain many causes of irritant contact dermatitis described in the complaint including dressing used after expiry date, skin preparation treatments used or patient allergy to compounds in the dressing.Without further information the failure mode cannot be ascertained.The device intended to be used in treatment has been returned and evaluated.No defect was found during visual inspection and functional evaluation.We have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.A clinical investigation was carried out.It was concluded: ¿the information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).It was further communicated, the area of the reported itching and blisters was washed with light salt water and subsequently the dressing was replaced.However, without the relevant clinical information or the dressing, neither the root cause nor the patient impact could be determined.Should additional relevant medical information be provided, this complaint will be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.¿ the users of the reported product are advised to consult the device ifu, to delineate future occurrences of the reported issue.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.As with all adhesive products some irritation can occur during application and removal, particularly on patients with sensitive skin.We have not been able to confirm a relationship between the event and the device or identify a root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• Type of Device: 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
• MDR Report Key: 10615156
• MDR Text Key: 209443072
• Report Number: 8043484-2020-03082
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: 201921
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK PICO; UNK PICO
• Patient Outcome(s): Required Intervention