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

Model Number SCF330

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Use of breast pumps is not known to cause or contribute to this event.This report has been submitted following a retrospective review of past complaints.Device not returned by the consumer.

Event Description

The consumer claims to have had infectious matistis in her chest following the use of her manual breast pump.She also claims that the infection spread to the scar of her caesarean section and has caused an abscess in the scar, which has lasted a month.

Manufacturer Narrative

Use of breast pumps is not known to cause or contribute to this event.This report has been submitted followings a retrospective review of past complaints.Corrected data: indicated that the manufacturer was located in the us instead of the (b)(6).

Event Description

The consumer claims to have had infectious mastitis in her chest following the use of her manual breast pump.She also claims that the infection spread to the scar of her caesarean section and has caused an abscess in the scar, which has lasted a month.

• Brand Name: PHILIPS AVENT MANUAL BREAST PUMP
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford, ; UK
• Manufacturer (Section G): PHILIPS ELETRONICS UK; philips electronics uk limited; lower road; glemsford, suffolk co10 7qs, CO10 7QS; UK CO10 7QS
• Manufacturer Contact: nina ruiz ; 1600 summer st.; stamford, CT 06912
• MDR Report Key: 6188452
• MDR Text Key: 62794534
• Report Number: 8021997-2016-00005
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other