MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED AVENT; MANUAL BREAST PUMP

Model Number SCF330

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: AVENT
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford, ; UK
• MDR Report Key: 6529178
• MDR Text Key: 73906443
• Report Number: 8021997-2017-00002
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• PMA/PMN Number: K101538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SCF330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other