MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LTD. PHILIPS AVENT NIPLETTE; MANUALBREAST PUMP

Model Number SCF 152/02

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 03/05/2014

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2014 consumer stated she has an inverted nipple and decided to try the niplette.Consumer was using the full force of the niplette.The consumer was educated on the dfu that excessive suction force on the nipple can cause bleeding to occur.Consumer stated she wanted to try the product again before returning.Will follow up again with the consumer in a week.

Event Description

On (b)(6) 2014 received a call from the consumer.Consumer states that the philips avent niplette caused bleeding on the left nipple.

• Brand Name: PHILIPS AVENT NIPLETTE
• Type of Device: MANUALBREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LTD.; glemsford ; UK
• Manufacturer Contact: mary smith ferreira ; 1600 summer st.; stamford, CT 06905 ; 2033515949
• MDR Report Key: 5971422
• MDR Text Key: 55578119
• Report Number: 8021997-2014-00003
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952035
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SCF 152/02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other