Catalog Number ER8125 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/20/2023 |
Event Type
Injury
|
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.The lot number and the item number are not known.
|
|
Event Description
|
According to available information, this device required replacement due to migration.The reservoir migrated down toward the groin on the left side.Only the reservoir was replaced.No other adverse patient effects were reported.
|
|
Manufacturer Narrative
|
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
|
|
Search Alerts/Recalls
|