MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE (ITEM #UNK)

Model Number 9207010/57XXX

Device Problems Crack (1135); Loose or Intermittent Connection (1371); Device Slipped (1584); Scratched Material (3020)

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

Event Date 01/26/2015

Event Type  malfunction  

Event Description

The customer reported to customer service that the transformer housing of her pump in style breast pump has two cracks at the top of the housing.Also one screw has fallen out and the other one is loose.The underlying electronics are exposed, causing a safety risk.

Manufacturer Narrative

The customer reported that there is a breach in the transformer housing.She did not report of any fire, spark or injury.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.The cause of the breach in the rev n transformer has not been determined at this time.It is currently being investigated under (b)(4).

• Brand Name: PUMP IN STYLE (ITEM #UNK)
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4535072
• MDR Text Key: 5516725
• Report Number: 1419937-2015-00051
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/57XXX
• Device Catalogue Number: 9207010/57XXX
• Device Lot Number: REV N/3113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/26/2015
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: No
• 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