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

Catalog Number	66803126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a npwt with a renasys edge pump placed on the patient's left axilla, the care team at the wound clinic discovered an abscess in the patient's right rib area during an appointment on (b)(6) 2024.The npwt was discontinued, and the patient was advised to seek further care for the abscess at the hospital.The patient was admitted to the hospital on (b)(6) 2024 and discharged on (b)(6) 2024.The npwt has not been resumed; however, the patient has an appointment at wound clinic scheduled for (b)(6) 2024.Further information is unavailable.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Given the nature of this case, the device was not expected to be returned, furthermore, there is no allegation of a device performance issue.The manufacturing records and processes for the reported device contain no contributory factors, records confirm that this device was manufactured, meeting the required specifications.There were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Historical review details no previous cases of this nature, and there are no open nor closed escalation actions.Related to this event type.A review of the product risk files, find the combination of product, event type and associated harms are anticipated, with no updates required.A medical review concluded, based on the limited information provided, it cannot be concluded how the reported abscess in the patient¿s right rib area is linked to the wound and use of npwt to the patient¿s left axilla (space between the side of the thorax and the upper arm).An abscess is a form of a pus that can affect any part of your body is caused by a bacterial infection.Since no results of a microbiological analysis were received, further assessment regarding these circumstances could not be performed.However, the renasys edge clinical manual does warn: ¿monitor patient for any signs of local of systemic infection.As negative pressure wound therapy is not intended to directly treat infection, contact treating clinician immediately if there are any signs of systemic infection or advancing infection at wound area.¿ therefore, a procedural variance could not be rule out as the likely cause of this adverse event.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: RENASYS EDGE PUMP
• Common Device Name: 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
• 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: 19653717
• Report Number: 8043484-2024-00065
• Device Sequence Number: 12411255
• Product Code: OMP
• UDI-Device Identifier: 05000223498634
• UDI-Public: 05000223498634
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K223041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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 Catalogue Number: 66803126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female