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

Model Number 24501879

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Customer was phoned and emailed a total of 4 times requesting return of the breast pump base to ameda, inc.To investigate the cause of battery leakage.As of this date, the pump base has not been returned to ameda therefore no visual examination or evaluation could be conducted.If the pump base is returned at a later date, a supplemental medwatch will be filed once investigation is completed.

Event Description

Customer contacted ameda, inc.On 10/26/2017 to report her purely yours ultra breast pump leaked dark fluid from the battery compartment while pumping in her car on (b)(6) 2017.She uses battery power to operate her breast pump when driving.Customer states the batteries were new out of the package.She had the pump base positioned on her lap while pumping.She felt a burning sensation on her left thigh then noted black fluid leaking from the battery compartment onto her leg.Customer estimates the size of the burn to be a half dollar in the center of her left thigh.Her leggings were not burned however her skin became red, blistered and later scabbed within 1 day.She inquired about burn care from her cardiologist she had an appointment with the next day.He did not recommend any special treatment of burn site but to keep area clean.Burn area healed within 2 days after incident.

• 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: 7049509
• MDR Text Key: 92656154
• Report Number: 3009974348-2017-00298
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725021484
• UDI-Public: (01)00810725021484(21)
• 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
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24501879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• 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
• Patient Age: 30 YR