MAUDE Adverse Event Report: HANDI-CRAFT CO DR BROWN'S; DOUBLE ELECTRIC BREAST PUMP

Model Number S1006

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/28/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, case (b)(4) reported that she had been diagnosed by a physician with mastitis due to a clogged milk duct.

• Brand Name: DR BROWN'S
• Type of Device: DOUBLE ELECTRIC BREAST PUMP
• Manufacturer (Section D): HANDI-CRAFT CO; saint louis MO
• Manufacturer Contact: eric paddock ; 4433 fyler ave.; saint louis, MO 63116-0000 ; 3147732979
• MDR Report Key: 3787181
• MDR Text Key: 4433472
• Report Number: 3008138005-2014-00002
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2014

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
• Device Model Number: S1006
• Device Lot Number: PO 16108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/24/2014
• 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