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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Event Description
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It was reported by the patient that the cover patches are irritating her skin as well.The patient stated that she has sensitive skin, and she contacted her doctor who told her to use paper tape, which also irritated her skin.The patient also requested more electrodes.No additional patient consequences have been reported.
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Manufacturer Narrative
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Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.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 the cover patches are irritating her skin as well.The patient stated that she has sensitive skin, and she contacted her doctor who told her to use paper tape, which also irritated her skin.The patient also requested more electrodes.No additional patient consequences have been reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The device not 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.B4: date of this report added.G1: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: component codes added 772 - cover.H6: impact code added 4648 - insufficient information.H6: device code updated to 2682 - patient-device incompatibility.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.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.
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Search Alerts/Recalls
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