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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH UNKNOWN INTRODUCER KIT DH EF PERC PLACEMENT PRODUCTS

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HALYARD HEALTH UNKNOWN INTRODUCER KIT DH EF PERC PLACEMENT PRODUCTS Back to Search Results
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.
 
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Brand NameUNKNOWN INTRODUCER KIT
Type of DeviceDH EF PERC PLACEMENT PRODUCTS
Manufacturer (Section D)
HALYARD HEALTH
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V.
circuito industrial no.40
colonia obrera
nogales, cp
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key6955843
MDR Text Key113525952
Report Number9611594-2017-00133
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/17/2017 Patient Sequence Number: 1
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