MAUDE Adverse Event Report: AMEDA INC. HYGIENIKIT; PUMP, BREAST NON-POWERED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Rash (2033)

Event Date 07/31/2014

Event Type  Injury  

Event Description

The customer contacted ameda on (b)(6) 2014 via phone call.She stated that she developed a red rash when using the hygienikit flanges.

Manufacturer Narrative

The customer has been under the care of a lactation consultant and has been using a cortisone cream and lanolin preparation to manage her symptoms.The customer has declined an offer to speak with ameda's lactation consultant.Three voice mail messages were left with the customer to further assess her rash and one voice message left further assess her rash and one voice message left asking customer to provide the flange lot number, located on package insert.To date, the customer has not returned the calls.No product return is expected.

• Brand Name: HYGIENIKIT
• Type of Device: PUMP, BREAST NON-POWERED
• Manufacturer (Section D): AMEDA INC.; buffalo grove IL
• Manufacturer Contact: 485 half day rd. suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 4101601
• MDR Text Key: 4762947
• Report Number: 3009974348-2014-00027
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/31/2014

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other