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

Model Number	34151
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a patient received a burn from a sterilization wrap in the operating room.No additional information provided.
Additional 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).

• Common Device Name: STERILIZATION WRAP
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6499896
• Report Number: 1054380-2017-00001
• Device Sequence Number: 1331280
• Product Code: FRG
• UDI-Device Identifier: 30680651341519
• UDI-Public: 30680651341519
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Model Number: 34151
• Device Catalogue Number: 991034151
• Device Lot Number: LT5563
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 05/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other