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Model Number 24502082 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Burn(s) (1757)
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Event Date 09/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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The returned product was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed.The returned product was assessed for indications of malfunction or thermal event.The returned product was assessed for functionality and met functional specifications.Dark grey substance, e.G battery acid, was observed inside the battery compartment.Internally, no signs of foreign substance, burning, melting or charring were observed.The returned batteries were observably damaged.Additional testing confirmed that batteries may leak when the upper middle battery is placed incorrectly, with the positive and negative end reversed.
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Event Description
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Customer contacted ameda, inc.On (b)(6) 2016 to report pumping with the purely yours breast pump on this same date using battery power.She had her hands underneath the pump base as she expressed her milk.She reports hearing a gurgle sound from the base and felt hot fluid on her right hand.She noted the fluid was leaking from the battery compartment, and was dark.She stopped pumping, threw away the breast milk she just expressed and noted a small red burn between her small and ring fingers near the palm of her hand.The area was red, slightly swollen but not blistered.She ran her hand under cold water and did not seek medical attention for the burn.Customer later removed the door of the battery compartment, finding some batteries had exploded.
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Search Alerts/Recalls
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