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 Problem
Skin Inflammation/ Irritation (4545)
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Event Date 04/22/2022 |
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 patient that she did the time test with the 63b electrodes, and they irritated her skin.The patient's doctor advised to discontinue treatment due to the irritation from the electrodes.The patient was not prescribed any medication.
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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 patient that she did the time test with the 63b electrodes and they irritated her skin.The patient's doctor advised to discontinue treatment due to the irritation from the electrodes.The patient was not prescribed any medication.
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Search Alerts/Recalls
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