Model Number P400X4D |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fever (1858); Pain (1994); Swelling/ Edema (4577)
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Event Date 11/12/2022 |
Event Type
Injury
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Event Description
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Fill volume: 550 ml.Flow rate: 4ml/hr.Procedure: laparoscopy for endometriosis.Cathplace: x2 catheters placed bilateral lower abdomen.Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.It was reported, that on (b)(6) 2022, the patient who had a dual onq pump developed pain, swelling, warmness, pus, and redness at the catheter insertion site four (4) days post op (at approximately 1 pm).The pump was removed due to the patients reported pain; the black tip(s) was present on both catheter tips, the pump(s) were not empty.The patient was advised to seek medical attention as soon as possible.The patient¿s current condition was not provided.Additional information received (b)(6) 2022 the patient¿s mother reported, the doctor prescribed antibiotics twice daily for 14 days.Additionally, four days later the patient was experienced redness, swelling, and pus to catheter insertion site on the left side only; the patient reportedly was running a low-grade fever of 101°f.
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2022 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Manufacturer Narrative
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The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 05 jan 2023 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Search Alerts/Recalls
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