Model Number RIGID SADDLE RING |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
Crd_985 - arb pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 34mm rigid saddle ring was implanted into a patient.On (b)(6) 2023, elevated glucose levels were observed and medication was administered.The patient is reported to be discharged.
|
|
Manufacturer Narrative
|
An event of elevated glucose levels was reported.Information from field indicated that medication was administered.There was no allegation of malfunction against the abbott device or procedure.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Event Description
|
Crd_985 - arb pmcf, patient site id: (b)(6).Subsequent emdr: subsequent to the previously filed report, additional information was received that the patient experienced migraines about three times a week, which started after the procedure.There was no intervention or treatment reported.
|
|
Manufacturer Narrative
|
An event of elevated glucose levels and migraines about three times a week was reported.There was no intervention or treatment reported.There was no allegation of malfunction against the abbott device or procedure.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Search Alerts/Recalls
|