|
It was reported that in a study testing the effectiveness and safety of a novel gel dressing in the management of neuropathic leg ulcers in diabetic patients, the patients were then randomized into 2 different groups: group a (using vulnamin® gel and polyurethane film biocclusive® gel) and group b (treated with the inert vehicle of the gel and polyurethane film biocclusive® gel).All patients received 4-layer compressive bandaging (profore®, smith & nephew).During the study there were 5 reports of pain/ discomfort from the patients (case-(b)(4)), 9 adverse events of infective episodes (case-(b)(4)), some adverse events of maceration (case-(b)(4) and some adverse events of skin sensitization (case-(b)(4)).It is unknown how many patients were having this problems and how were they treated.
|
|
The devices, used in treatment, have not been returned for evaluation.Therefore, the root cause cannot be determined and a relationship between the devices and the events reported cannot be established.As no product code or batch/lot number has been provided, we are unable to conduct a review of the device¿s history.However, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported events has been reviewed, revealing further instances.This investigation is born from the review of an historic clinical trial.However, 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.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the associated risk files found various failure modes leading to pain such as, insufficient padding under dressing, too much pressure when wrapping the dressing and pins and clips used to hold dressing in contact with skin.The file also contains multiple causes of local infection including damaged packaging, damaged dressing and poor patient compliance.Maceration is included in the file due to dressing getting wet, poor application technique or expired bandages.The file also quotes type 1 and 4 sensitization as results from latex allergy, insufficient coverage of layer 1, and layers being used individually.Without further information into the causes of these harms a more precise failure mode cannot be stated.The file also contains the failure mode of the dressing being left on too long leading to light bleeding.The ifu and device labeling contain adequate warnings and caution in respect of the reported events, including, do not use on patients with an ankle brachial pressure index (abpi) of less than 0.8, or on diabetic patients with advanced small vessel disease.Should the patient develop pain or pale, cool or numb extremities distal to the dressing, the bandages should be promptly removed.If the patient has a very thin ankle or very prominent tibial crest, extra padding should be applied to these areas to prevent pressure necrosis.Failure to detect significantly reduced arterial flow can result in pressure necrosis, amputation or even death.This product has components that contain natural rubber latex which may cause allergic reactions in some individuals.The risk of arterial as well as venous disease rises with age.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
|
