COLOPLAST A/S IMAJIN DOUBLE LOOP URETERAL STENT KIT IN SILICONE; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
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Catalog Number AJ4U85 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/12/2023 |
Event Type
malfunction
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Event Description
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According to the available information, the stent did not open at the kidney end.The end of jj was not permeable, and it was impossible to pass guide through jj.
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Manufacturer Narrative
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After receiving this complaint, we searched for other complaints and we didn¿t find any other complaint on the lot number.The product reference (b)(6) lot number 9320415 is a kit.Checking the quality databases revealed no anomaly in relation to the described defect.Unfortunately, no sample is available from the customer and we cannot go further than the documentary investigation which didn¿t reveal any anomaly recorded during production.
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Search Alerts/Recalls
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