MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PICO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number UNKN05004900

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

Patient Problems Bacterial Infection (1735); Rupture (2208)

Event Date 09/14/2020

Event Type  Injury  

Event Description

On the literature article named "negative pressure wound therapy (npwt) in groin wounds after lymphadenectomy in vulvar cancer patients", it was reported that, during npwt using pico ¿ to treat vulvar cancer patients after lymphadenectomy to reduce the severity of healing disorders in the groin, 1 patient developed a deep wound rupture and a severe surgical site infection (ssi) by a anaerob bacteria (gram neg), therefore patient was treated with metronidazol 1g+heracillin 1gx3 for 21 days.Patient outcome is unknown.

Manufacturer Narrative

H10: 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 root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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 reduce 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, insertion of batteries and switching on of the pump.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.H6: updated codes.

• Brand Name: UNKN PICO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11984692
• MDR Text Key: 255673093
• Report Number: 8043484-2021-01445
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention