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

Model Number 24502082

Device Problem Fluid/Blood Leak (1250)

Patient Problem Burn(s) (1757)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

Customer was contacted twice by phone and twice by email requesting return of the breast pump base for evaluation.A prepaid expedited (b)(6) return label was provided for her use.Customer has not returned the breast pump as of this date.If the breast pump is returned in the future, an investigation of the pump will be completed and a supplemental medwatch will be filed.

Event Description

Customer contacted ameda, inc.On (b)(6) 2017 to report pumping with the purely yours breast pump that day using battery power.She states she only uses batteries and never the ac adapter for power.Customer reports the batteries suddenly popped open on (b)(6) 2017 and dark fluid began leaking from the battery compartment onto her pump, pump pieces and hands.Customer placed her hands under cold running water to ease the tingling in her hands.She denies her hands being red, however she contacted her healthcare provider about this incident.It is unknown what advice the healthcare provider had for her.

• Brand Name: PURELY YOURS
• 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: 6594430
• MDR Text Key: 76070705
• Report Number: 3009974348-2017-00271
• 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
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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: 26 YR