Model Number SCF334 |
Device Problems
Use of Device Problem (1670); Device Operates Differently Than Expected (2913)
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Patient Problem
Inflammation (1932)
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Event Type
Injury
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Manufacturer Narrative
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An inflammation of the breast tissue can occur following clogged mammary ducts being left untreated or as a secondary effect caused by bacteria.Use of breast pumps is not known to cause or contribute to this event.The device has been designed according to safety standards and is safe to use when used according to the dfu.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.
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Event Description
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The consumer initially called indicating that her pump had stopped working after a couple of minutes of trying to use the product.Approximately two months later, she called back indicating that developed a breast inspection, mastitis, which she claims made her baby sick.
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Manufacturer Narrative
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An inflammation of the breast tissue can occur following clogged mammary ducts being left untreated or as a secondary effect caused by bacteria.Use of breast pumps is not known to cause or contribute to this event.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.Additional information:.The device in question was tested by the manufacturer and was found to be functioning within specifications.No failure was found.
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Event Description
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The consumer initially called indicating that her pump had stopped working after a couple of minutes of trying to use the product.Approximately two months later, she called back indicating that developed a breast infection, mastitis, which she claims made her baby sick.
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Manufacturer Narrative
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An inflammation of the breast tissue can occur following clogged mammary ducts being left untreated or as a secondary effect caused by bacteria.Use of breast pumps is not known to cause or contribute to this event.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.Additional information:.The device in question was tested by the manufacturer and was found to be functioning within specifications.No failure was found.
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Event Description
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The consumer initally called indicating that her pump had stopped working after a couple of minutes of trying to use the product.Approximately two months later, she called back indicating that developed a breast infection, mastitis, which she claims made her baby sick.
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Search Alerts/Recalls
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