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

Model Number SCF332

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 07/12/2015

Event Type  Injury  

Event Description

On 07/12/2015 customer claims her daughter was using the pump and after 15 mins of use noticed she was not getting any milk, when she went to remove the pump the daughter had blisters which had opened with removal.Customer had reported they were going to get medical attention but had not yet at the time of the call.

Manufacturer Narrative

On 11/11/2015 product was not returned for evaluation.Based on this event, no further corrective or preventive action is deemed necessary.We will continue monitoring these events in post market surveillance.

• Brand Name: PHILIPS AVENT BREAST PUMP
• Type of Device: MBREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford ; UK
• Manufacturer Contact: mary smith ferreira ; 1600 summer st; stamford, CT 06905 ; 4254878169
• MDR Report Key: 4995459
• MDR Text Key: 23084963
• Report Number: 8021997-2015-00008
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• 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: Followup
• Report Date: 07/29/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• 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