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Model Number 21-7302-24 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
Abdominal Pain (1685)
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Event Type
malfunction
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Manufacturer Narrative
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Operator of device is unknown.No information has been provided to date.
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Event Description
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It was reported that the patient experienced abdominal pain when using the cassettes.The reported product fault occurred while in use with the patient.The product issue did not cause or contributed to patient or clinical injury.No additional information, details, or dates available.
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Manufacturer Narrative
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Other text: additional information provided in h6 and h10.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.
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Search Alerts/Recalls
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