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

Model Number 66024008

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

Patient Problems Itching Sensation (1943); Rash (2033); Contact Dermatitis (4546)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during, the use of a iv3000 1 hand 10x12cm ctn 50 during 10 hours, the patient experienced itching and discomfort, red rash and maculopapular rash was found at the covered area.This adverse event was treated with ketoconazole applied locally.The rash disappeared about 1 day later.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.There is nothing to indicate that the device was responsible for the event.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 a complaint history review found further instances of the reported event in the last 3 years.There is nothing to indicate that this is outside of acceptable rates of occurrence.A clinical review concluded that it was not possible to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Probable root cause for the issue may be incorrect application of the dressing or improper preparation of wound area, or patient sensitivity to product or an existing skin condition.It may also be that the incorrect dressing was used for the type of wound.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device including skin preparation and dressing application.It states "this dressing should be used on iv sites only.If a film dressing is required for open wounds such as pressure sores, burns or donor sites, opsite flexigrid should be used" the alleged failure mode and any associated harm is mitigated in the risk files for this product.This investigation is now complete with no corrective actions required.Smith + nephew will continue to monitor for any adverse trends relating to this product range.D4.

• 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
• 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: 12562067
• MDR Text Key: 274260442
• Report Number: 8043484-2021-01826
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417406
• UDI-Public: 05000223417406
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66024008
• Device Catalogue Number: 4008
• Device Lot Number: 1921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KETOCONAZOLE TOPICAL.; KETOCONAZOLE TOPICAL.
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male