MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN RENASYS; 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); Skin Disorders (4543)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).(b)(6).Frear, c.C., cuttle, l., mcphail, s.M., chatfield, m.D., kimble, r.M., & griffin, b.R.(2020).Randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children.Journal of british surgery, 107(13), 1741-1750.Doi: 10.1002/bjs.11993.

Event Description

On the literature article named "randomized clinical trial of negative pressure wound therapy as an adjunctive treatment for small-area thermal burns in children", it was reported that, during negative pressure wound therapy with a renasys touch to treat burns, one (1) patient discontinued therapy because they presented wound maceration.It is unknown whether if, or how, the adverse event was treated.Patient outcome is unknown.

Manufacturer Narrative

H3, h6: we have not had the opportunity to evaluate the complained device.All supplied information has been reviewed and we are not able to determine a root cause or relate the reported issue to a device failure.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Maceration can occur during use, as detailed in the instruction for use, please monitor for signs of maceration, frequent dressing changes may be required on heavily exudating wounds.A documentation review has been conducted, confirming previous complaints of this nature.Without a valid device serial number, a thorough device history cannot be completed.The instructions for use and risk files, mitigate the reported issue with no updates required.This investigation is now completed with no escalations or corrective action deemed necessary.Smith and nephew cannot confirm the reported device but can confidently confirm all products are manufactured and released according to final product specification, with stringent control measures in place to capture any manufacturing or material deficiencies.

• Brand Name: UNKN RENASYS
• 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: 12647506
• MDR Text Key: 276878761
• Report Number: 8043484-2021-01876
• Device Sequence Number: 1
• Product Code: OMP
• 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,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other