MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS F SMALL W/SOFT PORT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66020794

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

Patient Problems Discomfort (2330); Impaired Healing (2378)

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, while using an unknown renasys on a pressure injury (possibly stage 3) located on the patient¿s left ischial tuberosity.The patient is seeing little progress and feels the wound is actually getting worse.The wound is approximately 3.5cm deep and now a tunnel has been identified in it.Also nurses do attempt to debride and advised they use the plurogel to keep the wound moist.This adverse event is still ongoing, and it is unknown what actions will be taken to solve it.

Manufacturer Narrative

D4: unique identifier (udi) # h6: health effect - impact code and health effect - clinical code.Section h3, h6: the product was not returned for evaluation.A documentation review was performed.A review of the batch records could not be completed, no identifiable batch has been provided, however this case is not reporting a product deficiency the case is reporting infection following npwt.Complaint history has revealed no other cases, during the period reviewed.There are no open nor closed escalation actions within the scope of this investigation.Non are considered.The risk management documentation for renasys touch has been reviewed.The failure and subsequent foreseeable harm of delayed wound healing is anticipated in which also references application also ¿user applies concurrent therapy to the wound which leads to ineffective transmission of npwt through foam and gauze: therapeutic benefits of npwt are lost¿.The current risk files are considered acceptable.The ifu has been reviewed, which reveals contributory factors and contraindications and are summarised within the medical review.Medical review concluded, presence of eschar is a contraindication, consequences of ineffective debridement includes delayed healing, the filler material should be in intimate contact with the wound bed contour, tissue adherence may be reduced by use of a contact layer, decreasing the pressure, and/or increasing the frequency of the dressing changes, gauze/foam combination therapy may be of benefit for optimizing the best wound healing environment and this option is dependent on the individual wound characteristics and clinical judgment, and know when to stop or change treatment: no improvement/reduction in size is seen in the wound bed following two consecutive dressing changes.¿ as of the date of this medical investigation, no clinical documentation or photos have been provided for assessment.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.In conclusion: based on the limited documentation provided, definitive clinical factors have not been identified to have contributed to the reported event; however, the patient-specific therapy details and patient nutritional status are unknown and cannot be ruled out as a potential underlying etiology.Additionally, it is unknown if the reported use of the competitor hydrogel has contributed to the reported event.The user manual does caution that viscous (drainage) may contribute to dressing occlusion and the clinical guidelines outline that intermittent therapy is not recommended for wounds with tunnels, ineffective debridement may delay healing, and know when to stop or change treatment if no wound bed improvement is seen within two (2) consecutive dressing changes.The patient impact beyond the reported delayed healing, pain from debridement at dressing changes, the newly identified wound tunnel, and emotional distress in this ongoing event cannot be determined.No further medical assessment can be rendered at this time.The probable cause remains unknown.Factors may include use or competitor product or contraindications not observed.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.B5: describe event or problem, d1: brand name d4: catalog #.

Event Description

It was reported that, after switching from pico to renasys in the treatment of a 2.5 year pressure injury (possibly stage 3) located on the patient¿s left ischial tuberosity, the wound started to get worse.The wound is approximately 3.5cm deep and now a tunnel has been identified in it.The patient had used pico for over 2 years, but the nurses decided to place renasys on.The patient uses the renasys foam dressing kit with soft port (small).Careful debridement has been attempted to tease the slough away, for the patient is anticoagulated, yet this has been painful.The nurses have been placing plurogel onto the slough base to loosen and keep the wound moist.After an unrelated admission to a hospital, the nursing staff refused to continue plurogel in the wound as it is too thick, so this impairs renasys to deliver therapy through the black foam.This adverse event is still ongoing, and it is unknown what actions will be taken to solve it.

• Brand Name: RENASYS F SMALL W/SOFT PORT
• 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
• 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: 16304412
• MDR Text Key: 308855264
• Report Number: 8043484-2023-00009
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565127163
• UDI-Public: 00040565127163
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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 Operator: Lay User/Patient
• Device Model Number: 66020794
• Device Catalogue Number: 66020794
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male