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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-20 INTRODUCER KIT DH EF PERC PLACEMENT PRODUCTS

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HALYARD HEALTH MIC-KEY* G-20 INTRODUCER KIT DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98434-17
Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Fever (1858); Perforation (2001)
Event Date 09/16/2016
Event Type  Injury  
Manufacturer Narrative
The actual complaint product was not returned for evaluation. Root cause could not be determined. The device history record for aa6032r03 was reviewed and the product was produced according to product specifications. The patient died following using a medical product, but there was no suspected association between the death and the use of the product all information reasonably known as of 24 apr 2017 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 after receiving a gastrostomy on (b)(6) 2016, the patient experienced high fever and abdominal pain. X ray on (b)(6) 2016 showed free gas. An exploratory laparotomy was performed, and an anchor suture from the gastrostomy procedure was found perforating the stomach wall. The perforation was sewn over and the patient recovered from the surgery. The patient later died as a result of their cancer. The type of cancer was not reported. No further information has been provided.
 
Manufacturer Narrative
All information reasonably known as of 21 jun 2017 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).
 
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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 industial no.40
colonia obrera
nogales, cp
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key6521215
MDR Text Key73665830
Report Number9611594-2017-00070
Device Sequence Number1
Product Code KGC
UDI-Device Identifier10680651984347
UDI-Public10680651984347
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2017
Device Model Number98434-17
Device Catalogue Number991098434
Device Lot NumberAA6032R03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/25/2017 Patient Sequence Number: 1
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