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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
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MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE Back to Search Results
Model Number 57063/9207010
Device Problems Break (1069); Component Falling (1105); Crack (1135); Fail-Safe Problem (2936)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2014
Event Type  malfunction  
Event Description
The customer reported to customer service that the transformer for her pump in style advance breast pump was cracked in the corner and then she dropped the transformer which broke in half.This is a safety risk.In addition, customer stated that she discarded the transformer.
 
Manufacturer Narrative
The customer received a replacement transformer.The product involved in the complaint was discarded; therefore, the product evaluation cannot be performed.No conclusions can be made as to the cause of the event.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).
 
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Brand Name
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
Manufacturer (Section D)
MEDELA, INC.
mchenry IL
Manufacturer Contact
don alexander
1101 corporate dr.
mchenry, IL 60050
8004358316
MDR Report Key4350277
MDR Text Key5138490
Report Number1419937-2014-00921
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/05/2014
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 Number57063/9207010
Device Catalogue Number57063/9207010
Device Lot NumberREV N/ 3113
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date12/04/2014
Initial Date Manufacturer Received 12/04/2014
Initial Date FDA Received12/16/2014
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 Number1
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