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

Model Number SCF 334/02

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Tears (2516)

Event Date 04/22/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 customer claims that the funnels on the pump bodies are too small and are causing bleeding.Consumer stated she discovered a sharp edge to the plastic which caused a small cut on the ridge of her nipple.

Manufacturer Narrative

On 04/23/2015 product will be requested to be returned for eval.

Manufacturer Narrative

Additional information: on 05/22/2015 product was received for evaluation.

Manufacturer Narrative

Additional information: on 11/11/2015 "device works within spec.No visual damage was detected.No sharp edges were observed.Deep in the funnel there is an edge however in normal use (when applying the cushions as instructed in the dru), nipple will not get into contact with the ridge.The user did not follow instructions given in dfu".

• Brand Name: PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford ; UK
• Manufacturer Contact: mary ferreira ; 1600 summer st.; stamford, CT 06905 ; 2033515949
• MDR Report Key: 4740225
• MDR Text Key: 18926406
• Report Number: 8021997-2015-00003
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2015

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: Lay User/Patient
• Device Model Number: SCF 334/02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2015; 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other