(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 29-dec-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
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It was reported that a patient experienced an incident where 4 sutures fell off within 24 hours of the procedure.The cancer patient required another radiologically inserted gastrostomy, which meant the requirement of general anesthetic.Additional information received on 13-dec-2017 stated that the upon checking, all t bars were still in the abdominal wall.The sutures and locking discs were not kept and no pictures taken since they came out with the dressing, which was all disposed of.The patient experienced pain since this event occurred over the weekend.The patient developed peritonitis, had gastric leakage, and also had to have a laparoscopic procedure.She will have to wait between a few weeks to a month before attempting another tube placement.No additional information was received.
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