Model Number N/A |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)
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Event Date 04/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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Zimvie complaint (b)(4).Date of event: (b)(6) 2022.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported by the sales rep that the patient is having a skin irritation to the 72r electrodes.Per the patient, her skin was red, itchy, and blistered.No welts or swelling.The patient changed to new electrodes every 2 or 3 days and rotated the location at that time.She does not have sensitive skin.She is allergic to foam tape and has seasonal allergies.The patient does not take blood pressure medication.The patient spoke with her surgeon regarding the irritation, and he suggested a cortisone cream.The patient will perform a time test with the 63b electrodes provided and will return an example of the old electrodes.A return pouch has been sent to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.
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Event Description
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It was reported by the sales rep that the patient is having a skin irritation to the 72r electrodes.Per the patient, her skin was red, itchy, and blistered.No welts or swelling.The patient changed to new electrodes every 2 or 3 days and rotated the location at that time.She does not have sensitive skin.She is allergic to foam tape and has seasonal allergies.The patient does not take blood pressure medication.The patient spoke with her surgeon regarding the irritation, and he suggested a cortisone cream.The patient will perform a time test with the 63b electrodes provided and will return an example of the old electrodes.A return pouch has been sent to the patient.
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Search Alerts/Recalls
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