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

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).

• Type of Device: STERILIZATION 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 Key: 6499896
• MDR Text Key: 73021428
• Report Number: 1054380-2017-00001
• Device Sequence Number: 1
• Product Code: FRG
• UDI-Device Identifier: 30680651341519
• UDI-Public: 30680651341519
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141071
• Number of Events Reported: 1
• 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 Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 34151
• Device Catalogue Number: 991034151
• Device Lot Number: LT5563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other