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.
|
|
Search Alerts/Recalls
|
|