Model Number SCF330 |
Device Problems
Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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Use of breast pumps is not known to have caused or contributed to this event.The device has been designed according to safety standards and is safe when used in according to the directions for use.The device has been requested from the consumer for analysis.Device has not been received.
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Event Description
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The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well.She went to the hospital where a doctor diagnosed her with infiltrative mastitis.She had to take antibiotics; she had infection in her blood and a temperature of 40degc.She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk.The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
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Manufacturer Narrative
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Use of breast pumps is not known to have caused or contributed to this event.The device has been designed according to safety standards and is safe when used in according to the directions for use.The device has been requested from the consumer for analysis.N 7/20: the device returned from the consumer tested in accordance to specifications.No failure was detected.
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Event Description
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The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well.She went to the hospital where a doctor diagnosed her with infiltrative mastitis.She had to take antibiotics; she had infection in her blood and a temperature of 40degc.She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk.The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
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Manufacturer Narrative
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Use of breast pumps is not known to have caused or contributed to this event.The device has been designed according to safety standards and is safe when used in according to the directions for use.The device has been requested from the consumer for analysis.In 7/20: the device returned from the consumer tested in accordance to specifications.No failure was detected.
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Event Description
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The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well.She went to the hospital where a doctor diagnosed her with infiltrative mastitis.She had to take antibiotics; she had infection in her blood and a temperature of 40degc.She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk.The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
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Event Description
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The consumer is claiming that when using the device, she expressed small amount of milk and did not feel well.She went to the hospital where a doctor diagnosed her with infiltrative mastitis.She had to take antibiotics; she had infection in her blood and a temperature of 40degc.She claims to have used the device as specified in the manual, to have stored the device in the special box and to have sterilized the device prior to pumping milk.The consumer also alleges that the device is defective because sometimes it does not make a vacuum air leaks at the junction between the pump body and the bottle that was supplied with the device.
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Manufacturer Narrative
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Use of breast pumps is not known to have caused or contributed to this event.The device has been designed according to safety standards and is safe when used in according to the directions for use.The device has been requested from the consumer for analysis.(b)(6)2017: the device returned from the consumer tested in accordance to specifications.No failure was detected.(b)(6) 2019:.Corrected fields d10, g4, g5, h3 and h6.
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Search Alerts/Recalls
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