Model Number C8301 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
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Event Description
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Name of procedure being performed: na.Incoming inspection.Detailed description of event: facility: incoming inspection po#: (b)(6).We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.There are items require cer in this report.We found the foreign object looks like human hair.Please confirm the photo and let me know your investigation result.C8301 lot #1434437 - particulate: hair(1).Patient status: na.No patient involvement.Type of intervention: na.Incoming inspection.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.
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Event Description
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Name of procedure being performed: na (incoming inspection).Detailed description of event: [facility] incoming inspection po#(b)(4).We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.There are items require cer in this report.We found the foreign object looks like human hair.Please confirm the photo and let me know your investigation result.C8301 lot #1434437 - particulate: hair(1).Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).
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Search Alerts/Recalls
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