Catalog Number MTO-11142-AJ |
Device Problem
Difficult to Remove (1528)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
|
Event Date 02/25/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Potential lot# - 71f19l2387.
|
|
Event Description
|
It was reported that the user had a difficulty in removing the device after 1-day placement in the patient.The user gave the patient a general anesthetic, by which the device could be removed.No injury to the patient was reported.
|
|
Event Description
|
It was reported that the user had a difficulty in removing the device after 1-day placement in the patient.The user gave the patient a general anesthetic, by which the device could be removed.No injury to the patient was reported.Patient condition reported as "fine".
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
|
|
Search Alerts/Recalls
|