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

Model Number SCF332/01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(4) 2015 attempted to contact consumer.Requested a call back.Once contact is made, product return for eval will be requested.

Event Description

On (b)(6) 2015 consumer states after using the breast pump she developed mastitis.

• Brand Name: PHILIPS AVENT MANUAL BREAST PUMP
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford ; UK
• Manufacturer Contact: mary smith ferreira ; 1600 summer st; stamford, CT 06905 ; 2033515949
• MDR Report Key: 4995446
• MDR Text Key: 23084987
• Report Number: 8021997-2015-00009
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SCF332/01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other