Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pain (1994); Shock (2072)
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Event Date 10/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of event: (b)(6) 2021.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 was having pain and a shocking sensation at the application site.No further information is known.
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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 shock and pain.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.The following sections have been updated: b4: date of this report added d3: manufacturer updated g1: contact office updated g3: date received by manufacturer added g6: type of report updated h2: follow up type added h3: device evaluated by manufacturer updated to no h4: device manufacturer date added h6: impact code 4649 - unanticipated adverse device effect h6: clinical code 1994 - pain h6: clinical code 2072 - shock 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 h6: investigation conclusions added to 4315 - cause not established 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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Event Description
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It was reported by the sales rep that the patient was having pain and a shocking sensation at the application site.No further information is known.
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Search Alerts/Recalls
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