Catalog Number ES8822 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
Injury
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Event Description
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According to available information, this device required replacement due to a pump crack.Only the pump was replaced.No other adverse patient effects were reported.
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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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Manufacturer Narrative
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Based on examination of the returned product, it was concluded that the non-striated, dull, and smooth surfaces associated with the separation indicate that sufficient stress was exerted on the pump body.A separation of this type could then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.This issue and lot number are associated with a previously identified issue that was resolved in capa: 618925.
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Event Description
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According to the available information this inflatable penile prosthesis was revised due to pump cracked at pump.
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Search Alerts/Recalls
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