MAUDE Adverse Event Report: AMEDA, INC PURELY YOURS ULTRA; ELECTRIC BREAST PUMP

Model Number 24501649

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

Customer was contacted by phone and email multiple times in the past 3 weeks requesting return of the damaged car adapter for investigation by ameda labs.Customer was emailed 2 expedited pre-paid (b)(6) return labels for product return.As of this date, customer has not returned the product so no visual inspection or testing was completed.If product is returned to ameda, inc., a supplemental report will be filed.

Event Description

Customer contacted ameda, inc.On (b)(6) 2015 to report the ameda car adapter she was using in her car to power on the purely yours ultra breast pump seemed to not fit properly inside the car lighter.Customer states this poor fit resulted in part of the car adapter breaking off inside the lighter, leaving an exposed fuse which resulted in sparks being emitted inside the car.This fuse was removed by her husband with an object that did not conduct electricity.No one touched this part of the car adapter but the customer sensed that this piece was hot.Sparks did not come in contact with anyone in the car during this incidence.Therefore no injury, burn or property damage occurred.

Manufacturer Narrative

Product (car adapter) was received at ameda and evaluated for evidence of allegation on (b)(6) 2016.The allegation was not repeated and no evidence of malfunction was observed.

• Brand Name: PURELY YOURS ULTRA
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 5347400
• MDR Text Key: 35200939
• Report Number: 3009974348-2016-00187
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24501649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 33 YR