Catalog Number ULT8.5-38-25-P-6S-CLM-RH |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Code Available (3191)
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Event Date 07/13/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The patient required an additional procedure as a result of the product problem.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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Event Description
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It was reported that the device was placed in the kidney for nephrostomy drainage.The patient has the device replaced every 6 weeks and after the procedure was done successfully, the patient was discharged.The hub later separated and the patient had a new catheter put in the next day.
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Search Alerts/Recalls
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