The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of huaw0245 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (huaw0245) have been reported from the same facility.
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It was reported on (b)(6) 2017 that the dome migrated.No other information was reported, but has been requested.There was no reported patient injury.On (b)(6) 2017 - per the reporting facility, the child's parents were caring for the device on discharge home after receiving education from the facility's team.The device was intact but had migrated out of the patient's stomach.This was discovered due to the child complaining of pain, the presence of swelling and redness at the insertion site, and the device was no longer sitting flush against the skin; the shaft of the device was visible and usually on an angle there is an obvious lump at the site.There was no complication as a result of this event.
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