Catalog Number AA6418 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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, this device was difficult to inflate and deflate.During the inflation test before device placement, it was difficult to inject and remove water from the balloon.No other adverse patient effects were reported.
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Manufacturer Narrative
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After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9018807.In september, we received one used sample.After desinfection it was observed that the balloon was assymetric and blocked the way to inflate/deflate and caused the issue observed.Our subcontractor investigation concluded on raw material issue on balloons conducting to assymetry.Checking the quality databases revealed one corrective and preventive action are ongoing: monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending on balloon asymetry issue is followed and below the threshold.
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Event Description
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According to available information, this device was difficult to inflate and deflate.During the inflation test before device placement, it was difficult to inject and remove water from the balloon.No other adverse patient effects were reported.
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Search Alerts/Recalls
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