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

Catalog Number UNKNOWN

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

Patient Problems Impaired Healing (2378); Swelling/ Edema (4577)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a swelling of the leg (oedema) and enlargement of the wound related to the use of a pico device.Bleeding during dressing change was also reported.The incident occurred on (b)(6) 2020.The device had been fitted on (b)(6) 2020.No additional information is available at this time.

Event Description

It was reported there was swelling of the leg (oedema) and enlargement of the wound related to the use of a pico device.Bleeding during dressing change was also reported.The incident occurred on (b)(6) 2020.The device had been fitted on (b)(6) 2020.No additional information is available.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.As no batch/lot number was provided, a review of the device history records was not possible.The complaint history file contains further instances/related events of the reported event.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.The reported issue may be related to procedural technique.The users of the reported product are advised to consult the device labelling/ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.The medical review could not establish a link between the product and harm within this complaint.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.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11262829
• MDR Text Key: 229805969
• Report Number: 8043484-2021-00227
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other