|
Model Number AA8C141002 |
Device Problems
Material Split, Cut or Torn (4008); Unintended Deflation (4061)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
According to available information, this device was no longer able to be used due to a split.The patient's device was expelled.The patient stated the device slid out with the balloon deflated when he got up this morning.Patient kept the device.On inspection, the balloon appeared to have a split, however no part of the silicone material appeared missing.No other adverse patient effects were reported.
|
|
Search Alerts/Recalls
|
|
|