MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PICO

Catalog Number UNKN05004900

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

Patient Problem Localized Skin Lesion (4542)

Event Date 05/11/2021

Event Type  Injury  

Event Description

It was reported, on a double-blinded market research study, the clinician stated that he would not recommend pico because it does not have canister.Also that pico device macerates the skin very badly.There is no information regarding to when this adverse event occurred.

Manufacturer Narrative

The complaint was received as a result of issues being identified in a double blinded market research study.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 survey, 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 PICO
• Type of Device: UNKN PICO
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11898220
• MDR Text Key: 253124525
• Report Number: 8043484-2021-01276
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004900
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention