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

Catalog Number UNKN05004802

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

Patient Problems Bacterial Infection (1735); Skin Disorders (4543)

Event Date 07/01/2008

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).Yousef, a., angadi, d.S., nagare, u., & raymond, c.(2008).Home surveillance of leaking wounds after hip and knee arthroplasty: a prospective audit.Journal of wound care, 17(7), 289-291.Doi: 10.12968/jowc.2008.17.7.30519.

Event Description

On the literature article named "home surveillance of leaking wounds after hip and knee arthroplasty: a prospective audit", the authors of the study reported that, during usage of opsite post op dressing to treat post-surgical wounds, 18 patients develop pain, redness, and change in the amount or nature of discharge.A bacteriological examination was performed and it was positive for infection.The patients received oral antibiotics and responded satisfactorily to the treatment so the wounds healed without any other complications.Additional information is unknown.

Manufacturer Narrative

B5: literature citation: yousef a, angadi ds, nagare u, raymond c.Home surveillance of leaking wounds after hip and knee arthroplasty: a prospective audit.J wound care.2008 jul;17(7):289-91.Doi: 10.12968/jowc.2008.17.7.30519.Pmid: 18705229.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.A complaint history review was performed for the product family and event description, 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.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.We will continue to monitor for any adverse trends relating to all product ranges.

• Brand Name: UNKN OPSITE POST OP
• 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: 12546790
• MDR Text Key: 273779395
• Report Number: 8043484-2021-01793
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• 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