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

Catalog Number 66800795

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Impaired Healing (2378); Tissue Breakdown (2681); Skin Disorders (4543)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during a npwt applied after the patient underwent a grafting in the foot, the patient experienced extreme maceration of the wound and non-integration of the graft in the foot.It has been noticed that, when the dressing is used with an interface (in this case gauze with a petrolatum plate), it does not provide the pressure correctly and does not remove adequately the secretion, leaving the wound extremely moist.The current health status of the patient and the way this adverse event was solved is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, and with no other supporting evidence provided, the complaint could not be confirmed.All provided information has been reviewed and we have not been able to establish a relationship between the product and reported event, or determine a root cause.Use of gauze as a filler in wounds that are in a weight bearing location or have a moderate to heavy drainage may challenge the transfer of fluid and vacuum.Foam is recommended in these wounds.A medical review concluded that a thorough medical investigation could not be performed without further clinically relevant patient documentation, however procedural variance could not be ruled out as a possible root cause.Patient outcome could not be confirmed nor concluded beyond what is documented within the complaint.A complaint history review found further instances of the reported events.However, all product documentation has been reviewed and can confirm that the product was manufactured and released to specification, with instructions for use that contain adequate information to avoid maceration or extreme maceration.The associated risk file adequately mitigates the risk, with no updates required.This investigation is now complete, and it is deemed that the implementation of corrective actions is not necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS F MEDIUM 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: 12573804
• MDR Text Key: 274708116
• Report Number: 8043484-2021-01832
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565125923
• UDI-Public: 40565125923
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 66800795
• Device Lot Number: 2020031132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention