Catalog Number ES8920 |
Device Problems
Inflation Problem (1310); Self-Activation or Keying (1557); Failure to Deflate (4060)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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, the patient with this device is experiencing patient experiencing device cycling issues.The patient reports the device is very difficult to inflate, his hands are sore after trying to inflate, difficult deflation and auto-inflation each morning.No other adverse patient effects were reported.
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Manufacturer Narrative
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The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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Event Description
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According to the available information the patient reported experiencing device cycling issues.
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Search Alerts/Recalls
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