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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 36IN X 36IN

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HALYARD HEALTH KIMGUARD ONE-STEP* QUICK CHECK* STERILIZATION WRAP, KC 600, 36IN X 36IN Back to Search Results
Model Number 34151
Device Problem Thermal Decomposition of Device (1071)
Patient Problem Burn(s) (1757)
Event Date 03/30/2017
Event Type  Injury  
Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned when this report was filed. A review of the device history record is not possible as a valid julian date was not provided. Root cause could not be determined. All information reasonably known as of 10apr2017 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 patient received a burn from a sterilization wrap in the operating room. No additional information provided.
 
Manufacturer Narrative
(b)(4). All information reasonably known as of 04may2017 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 DeviceSTERILIZATION WRAP
Manufacturer (Section D)
HALYARD HEALTH
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
HALYARD LEXINGTON INC.
389 clyde fitzgerald road
linwood NC 27299
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key6499896
MDR Text Key73021428
Report Number1054380-2017-00001
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number34151
Device Catalogue Number991034151
Device Lot NumberLT5563
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2017
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

Patient Treatment Data
Date Received: 04/18/2017 Patient Sequence Number: 1
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