Model Number UNKNOWN |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problem
No Code Available (3191)
|
Event Date 09/09/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
All information reasonably known as of 8-nov-17 has been included in this health authority report.
Should additional information be obtained, a follow-up health authority report will be provided.
The information provided by halyard health represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.
Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.
This product incident is documented in the halyard health complaint database and identified as (b)(4).
|
|
Event Description
|
Per additional information received 30 oct 2017, the patient was almost (b)(6) with a severe neurological condition.
The device was placed on (b)(6) 2017.
The patient was returned to the hospital on (b)(6) 2017.
A ct scan was performed, which identified the free gas in the patient's abdomen.
An operation performed on (b)(6) 2017 identified the anchor in the ventricle wall.
|
|
Manufacturer Narrative
|
(b)(4).
The actual complaint product was not returned for evaluation.
Root cause could not be determined.
A review of the device history record is not possible as no lot number was provided.
All information reasonably known as of 17-oct-17 has been included in this health authority report.
Should additional information be obtained, a follow-up health authority report will be provided.
The information provided by halyard health represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.
Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.
This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Device not returned.
|
|
Event Description
|
It was reported that a (b)(6) year old boy had an unknown mickey device inserted with unknown introducer kit at the hospital.
Some days later, the patient arrived back at the hospital with free gas in the abdominal wall.
During examination, one of the anchor sutures was found in abdominal wall.
The hospital felt that this was the source of the gas.
The gastrostomy, including sutures, was removed, and a new gastrostomy was made.
The patient's status was unknown at the time this was reported to halyard.
Additional information has been requested but not yet received.
|
|
Search Alerts/Recalls
|
|