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Model Number EXN9341002 |
Event Date 03/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Event Description
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According to available information, though not verified, this patient experienced symptoms associated with pyelonephritis approximately 24 hours after the installation of this product for a lithotripsy procedure.The doctor noted that the cause of the infection could not be differentiated between this product, the installation procedure or how the patient cared for themselves post-procedure.It was reported that the patient was successfully treated with iv antibiotics.
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Search Alerts/Recalls
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