Model Number N/A |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Manufacturer Narrative
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The device was not 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.Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.
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Event Description
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It was reported by the patient that they are having a reaction to the 63b electrodes.It was later reported on (b)(6) 2022 the patient saw their doctor and was prescribed a cream for the irritation.The patient also stated they will continue treating.The patient was advised to try the time test when the skin heals.It was reported that no further information is available.
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Event Description
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It was reported by the patient that they are having a reaction to the 63b electrodes.It was later reported on (b)(6) 2022 the patient saw their doctor and was prescribed a cream for the irritation.The patient also stated they will continue treating.The patient was advised to try the time test when the skin heals.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and corrected information.The device was not returned to zimvie for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: health effect added 4545 - skin inflammation/ irritation.H6: device code updated to 2993: adverse event without identified device or use problem.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4114: device not returned.H6: investigation code added to 4119: insufficient information available.H6: investigation findings code added to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.
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Search Alerts/Recalls
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