|
Catalog Number DYND11552 |
Device Problem
Inflation Problem (1310)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/03/2024 |
Event Type
malfunction
|
Event Description
|
Balloon didn't inflate.
|
|
Manufacturer Narrative
|
It was reported by the customer contact that on 1/3/24, a "balloon did not inflate on a 6 fr foley".Due to this the foley was removed and replaced.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
|
|
Search Alerts/Recalls
|
|
|