MAUDE Adverse Event Report: PHILIPS ELECTRONICS UNK LTD. PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP; ELECTRIC BREAST PUMP

Model Number SCF322/01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 05/08/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2015 product was requested for evaluation.

Event Description

On (b)(6) 2015 consumer claims after using the breast pump for a few days, she has developed pain and soreness and a blister burst on her right breast.Consumer claims they are now unable to breast feed or express milk.

• Brand Name: PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UNK LTD.; glemsford ; UK
• Manufacturer Contact: mary smith ferreira ; 1600 summer st.; stamford, CT 06905
• MDR Report Key: 5971444
• MDR Text Key: 55570396
• Report Number: 8021997-2015-00005
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SCF322/01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other