|
Model Number ES40030 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Rash (2033)
|
Event Date 12/03/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
|
|
Event Description
|
The customer reported that a patient contacted them to report a skin irritation related to the electrode.This was the second skin irritation complaint reported by this patient.The patient was initially using the vermed electrode and was switched to the covidien soft-e electrode due to skin irritation.After four days using the covidien soft-e electrode, the patient removed the device and called to report her skin irritation did not improve, and her doctor advised her to stop wearing the device and prescribed prednisone.No previous skin allergies or sensitivities are known.
|
|
Manufacturer Narrative
|
Additional information the device history records (dhrs) were reviewed for the reported lot number.There were notes about issues, however these types of issues most likely would not cause the issue stated in the complaint report.The dhr reviews show that all acceptance criteria inspections were within acceptable limits during the production process.There were no samples received with this complaint, therefore an examination of the reported issue could not be made.From a root cause analysis perspective, the cause of the skin irritation is most likely attributed to skin preparation, skin condition or specific skin sensitivities.The issue can also be caused by repeatedly placing electrodes in the same position or area which can irritate the skin.Or placing the electrodes over already irritated skin.Biocompatibility testing is performed and gel was found to be non-cytotoxic, non-irritating and non-sensitizing.It is important to note that this test only provides confidence that 95% of the population will not have an adverse reaction.The use of this product requires an adherence to proper skin preparation protocols as documented on the product packaging.Improper application of the electrode, application to sensitive, irritated or broken skin, using the electrodes for longer than intended based on packaging instructions may cause adhesion or skin irritation issues.A risk assessment was performed which indicates skin irritation could be a result of low ph in the gel mix.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.No corrective or preventative actions are necessary.However due to the number of complaints received specific to this issue a corrective and preventative action (capa) has been opened to review and investigate any potential for product causes.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.
|
|
Search Alerts/Recalls
|
|
|