Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problems
Anxiety (2328); Numbness (2415); No Known Impact Or Consequence To Patient (2692); No Information (3190)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The event is currently under investigation.
|
|
Event Description
|
It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2006 at (b)(6) medical center.¿ it is alleged that patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.
|
|
Manufacturer Narrative
|
(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.
|
|
Event Description
|
It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2006 at (b)(6).¿ it is alleged that patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.
|
|
Manufacturer Narrative
|
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
|
|
Event Description
|
This additional information received on 4/28/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right femoral vein due to left leg dvt.Plaintiff is alleging transitory numbness in arm and anxiety.
|
|
Search Alerts/Recalls
|