FDA Adverse Event Death Summary report: N

MINIELECTRIC; LACTINA

MDR report key: 596073 · Received April 25, 2005

Report

Report Number
MW1035322
Event Type
Death
Date Received
April 25, 2005
Manufacturer
MEDELA, INC.
Product Code
HGX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
UY
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DUE TO FALSE AND MISLEADING ADVERTISEMENT IN THE BOX, INCOMPLETE AND MISLEADING INFO ON THE DIRECTIONS OF USE, AND OTHER MISLEADING ADVERTISEMENT, THERE MIGHT HAVE BEEN IN DOCUMENTED CASES DEATHS OF NEWBORNS AFTER ACQUIRING HIV, HEPATITIS, PERMANENT IMPAIRMENT DUE TO MASSIVE LOADS OF DIOXINS ACQUIRED THROUGH BREAST MILK PUMPED BY THE BREASTPUMP, PERMANENT PSYCHOLOGICAL DISABILITY DUE TO LACK OF BONDAGE ESTABLISHED WITH NATURAL BREAST FEEDING, DISABILITY AQUIRED AFTER LEAKAGE OF KNOWN TOXIC PRODUCTS THROUGH THE TUBING. ALSO THERE MIGHT BE IN OTHER CASES NOT STUDIES BY RPTR ACQUISITION OF OTHER DISEASES. THERE IS A BOOK ON THE SUBJECT THAT RPTR HAS. OTHER BREAST PUMPS OF OTHER MANUFACTURERS WHOSE FDA AUTHORIZATION WAS BASED ON MEDELA INC HAVE OTHER PROBLEMS AND ADVERSE EVENTS. THE PRESSURE AT WHICH THE MILK IS EXTRACTED DOES NOT VARY AS PROMISED BY THE COMPANY, PRODUCES HARM TO THE MOTHER, THERE IS NO WARRANTY THAT THE PRESSURE AT WHICH THE MILK IS EXTRACTED WILL RELEASE HORMONES AS IN NATURAL FEEDING THAT WILL SERVE THE ANTICONCEPTIONAL PURPOSE AT THE SAME RATE, THERE IS LEAKAGE OF MILK INTO SOME BREAST PUMPS AND IT MIXES WITH THE OIL AND MATERIALS INSIDE THE PUMP. THERE IS NO INDICATION AS HOW TO DISCARD THE PUMP ONCE USED OR DIRECTIONS TO DISCARD AS A CONTAMINATED BIOLOGICAL MATERIAL. ALSO THERE IS NO INDICATION OF POSSIBLE CONTAMINATION OF THE ENVIRONMENT. THE WORKING CONDITIONS OF THE BREAST PUMPS ARE NOT CHECKED BY AN OBJECTIVE PERSON OUTSIDE OF THE COMPANY, AS TO PRESSURE, LEAKAGE TO THE PUMP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MINIELECTRIC; LACTINA BREAST PUMP HGX MEDELA, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 * Death| L| R| S