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

Catalog Number 4008

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Date 03/05/2020

Event Type  Injury  

Event Description

It was reported that after using the dressing for one day, there is a 3x1cm blister around the dressing, and the skin felt itchy and red.Finally a backup dressing was used and applied burning cream for the blister.

Manufacturer Narrative

H10 h3,h6: 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 this failure mode in the past three years.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; ¿per description, the reported blister, redness, and itchiness was treated with an unknown cream, however the patient¿s current condition is unknown.Although, the above symptoms were reported, responses to clinical requests were not provided.Smith and nephew has not received adequate documentation to fully evaluate the root cause of the reported events.The patient impact beyond the reported could not be determined based.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.¿ a risk management review was carried out, which determined a possible root cause for the reported issue.The risk files for this product contains the failure mode of skin reactions occurring whilst using the dressing leading to type 4 sensitization reaction.A review of the ifu for this product did not identify any details which may have caused or contributed to the reported issue.We have not been able to confirm a relationship between the event and the device or identify a definitive 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 ; UK
• MDR Report Key: 10331636
• MDR Text Key: 200584052
• Report Number: 8043484-2020-02198
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04582111150998
• UDI-Public: 4582111150998
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: 1841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other