Catalog Number P310NUS |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Other, other text: b3: date of event is unknown, no information received to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the device has a broken case.Patient involvement is unknown.
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Event Description
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Additional information was received: the patient did not send in this device for repair, this request has been cancelled.Customer requested to disregard this request.No further details provided for the additional information asked.
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Manufacturer Narrative
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Email is: (b)(6).Com.H6 - evaluation codes: updated.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Search Alerts/Recalls
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