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 09/02/2020

Event Type  Injury  

Event Description

It was reported that for a week of iv3000 being used, the patient complained itchy , and blisters was found on the patient's skin.The dressing was replaced and the affected zone washed with light saline.Unknown if new dressing was a s&n backup.

Manufacturer Narrative

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 was used for treatment.As no samples were returned a product evaluation could not be carried out.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, however, that the affected zone washed with light saline and the iv3000 was subsequently replaced and the issue resolved.Therefore, no further medical assessment is warranted at this time.¿ 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.

Manufacturer Narrative

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 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 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.The device intended to be used in treatment has been returned and evaluated.No defect was found during visual inspection and functional evaluation.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, however, that the affected zone washed with light saline and the iv3000 was subsequently replaced and the issue resolved.Therefore, no further medical assessment is warranted at this time.¿ 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: 10614069
• MDR Text Key: 209408241
• Report Number: 8043484-2020-03080
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: 201921
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 01/05/2021
• Supplement Dates FDA Received: 11/06/2020; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention