Model Number AA61161002 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
Injury
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Event Description
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According to available information, this device required replacement due to a break.The patient was hospitalized in intensive care for second degree burns and had a device placed.The patient fell out of bed and ripped the device so that it was cut into two pieces.The balloon was removed from the bladder by cystoscopy and forceps.
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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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Manufacturer Narrative
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After receiving this complaint, we searched for other complaints and we didn't find any other complaints with the same lot number 8350399.Checking the quality databases didn't reveal any anomaly in connection with the described defect.We received one used sample.After disinfection sample was observed, tip's part was missing, it seems to be torn probably due to an excess of force.We estimate the incident of foley catheter in-situ rupture is more in favor of a misuse related to the patient handling in a context of falling from the bed.The risk identification is extract criq247 with risk 11402.
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Search Alerts/Recalls
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