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).B4: date of event: the event occurred sometime in (b)(6) 2023.D10: medical product: unknown.D10: therapy date: unknown.
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Corrections in b4: date of the report, b5: event description, d3: manufacturer, d4: udi, e: last name, g1: contact office, g6: type of report.Additional information in a2: dob, h4: device manufacture date, h6: component, investigation type, findings, and conclusions review of the information provided by the customer and along with findings from the investigation, indicate there are no systemic issues with the product or lot.Therefore, the bill of materials (boms), material certifications, master labels, and product drawings were not requested or pulled during this investigation.The approved suppliers were not contacted, and the product was not pulled from stock for evaluation.No physical and/or functional condition could be found after review of the certificate of conformance that could be considered a causal factor for the reported complaint.The reported claim could be associated with a side effect/clinical condition of the patient which is unknown.The reported condition is related to clinical factors beyond the scope of the device investigation covered in the complaint investigation as part of the manufacturing review.Issue evaluation ie-00840 was initiated to investigate the received complaints of irritation/rash developed from the electrodes/cover patches.Hhed-10-2017-001 evaluated the risk to the patient.Therefore, no further actions are required at this time.Highridge medical will continue to monitor for trends.This device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
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