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

Model Number SCF330/20

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Reaction (2414)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

This is the first time this type of incident has been reported.Latex is not a material component of the breast pump.It is always possible to have an allergic reaction to a material.However, this is very unlikely with this product, since allergies to both silicone, (the material of the breast pad), and polypropylene, (the material of our pumps), are very rare.Both materials are considered "inert" and have been tested to comply with the iso 10993 standard for biocompatibility, i.E., both materials are safe and should not cause allergic reactions.This device was also discarded by the consumer and cannot be evaluated.

Event Description

Consumer alleges to have received an allergic reaction from using a breast pump.She claims to have developed a rash over her right breast, up onto her neck and facial redness/swelling.She requested refund for her products.

• Brand Name: PHILIPS AVENT MANUAL BREAST PUMP
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford ; UK
• Manufacturer Contact: nina ruiz ; 1600 summer st.; stamford, CT 06905 ; 2033515949
• MDR Report Key: 5327320
• MDR Text Key: 34419013
• Report Number: 8021997-2015-00013
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2015

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: SCF330/20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/23/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other