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Catalog Number UNKNOWN |
Device Problem
Material Deformation (2976)
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Patient Problems
Abdominal Pain (1685); Vomiting (2144); Swelling/ Edema (4577)
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Event Date 09/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter postal code: (b)(6).Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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As reported in the literature by corbett & dickson (2005), an unspecified cook 4.7 french soft-flex multi-length stent knotted within a pediatric patient.The stent was originally placed for an obstructed mega-ureter after pyeloplasty, to protect an anastomosis and ensure post-operative kidney drainage.The stent was removed eight weeks later.Resistance was encountered during withdrawal of the stent and a knot was found in the proximal loop after removal.The authors state that the stent was not difficult to remove but some trauma did occur, which put the kidney at risk.Twenty-four hours later, the patient developed abdominal pain and vomiting.Ultrasound noted gross left hydronephroureter, and the patient was admitted to the hospital for observation.The symptoms subsided over the following 48 hours without any intervention.Lab values and blood pressure remained normal.Serial ultrasounds showed a return to pre-operative dimensions over the following 14 days.The authors conclude that multi-length stents should probably be avoided in children and that users should be aware of the possibility of knotting, especially if resistance is encountered upon stent withdrawal.Reference for article: corbett, h.J.& dickson, a.P.(2005).Knotting of a ureteric stent in a child.International urology and nephrology (37), p.493-494.Doi: 10.1007/s11255-005-2084-1.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.Correction: this pr was determined to be a duplicate of (b)(4) (mdr #: 1820334-2016-00336) and has already been reported.There is no new information to report.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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