MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN OPSITE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKN05004800

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/01/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).Wynne, r., botti, m., stedman, h., holsworth, l., harinos, m., flavell, o., & manterfield, c.(2004).Effect of three wound dressings on infection, healing comfort, and cost in patients with sternotomy wounds: a randomized trial.Chest, 125(1), 43-49.Doi: 10.1378/chest.125.1.43.

Event Description

On the literature article named "effect of three wound dressings on infection, healing comfort and cost in patients with sternotomy wounds: a randomized trial", the authors of the study reported that, when using an opsite dressing to treat postoperative patients with sternotomy wounds, 5 patients developed an unspecified deep sternal wound infection (involving muscle, bone and/or mediastinum), within a time range of 1 to 5 postoperative days.In conjunction with this adverse event, one of the following interventions were conducted: excision of wound tissue, a positive wound culture finding or treatment with antibiotics, although it is not specified which one was conducted for each patient/adverse event within the study.

Manufacturer Narrative

H3, h6: the complaint was received as a result of issues being identified in a literature article.Due to this, no specific product details or batch/lot numbers have been available to the investigation.As a result of this, no device history review was possible as both a product number and lot number are required to find the relevant documents of manufacture.A complaint history review however was performed as this can be carried out on the product family of "opsite" and event description, and does not required a product code or lot number.This revealed that there have been further instances in the past three years.According to the article, the devices were being used in patient treatment.The devices used for treatment have not been returned to smith and nephew for analysis.We have therefore not been able to confirm a relationship between the event and the device or identify a definitive root cause.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The medical review could not establish a link between the product and harm within this complaint and therefore additional rmr is not required.Users of the device are advised to consult the instructions for use, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including advice on application and removal of dressings.This investigation has now been closed.No further actions by smith and nephew are deemed necessary at this stage.Smith and nephew acknowledge customer concern and are grateful for all feedback on our products, as this information is extremely valuable to us, as we are continually investigating ways to develop and improve the full range of products that we provide.We will continue to monitor for any adverse trends relating to all product ranges.

• Brand Name: UNKN OPSITE
• 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: 12561965
• MDR Text Key: 274265024
• Report Number: 8043484-2021-01799
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

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: UNKN05004800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/04/2022
• 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
• Patient Outcome(s): Hospitalization; Other