MAUDE Adverse Event Report: HALYARD HEALTH 24-HOUR ORAL CARE KIT WITH BALLARD TECHNOLOGY, Q4 WITH CHG; VAP ORAL CARE PRODUCTS

Model Number	97014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient codes: no code available - angioedema.There is no information provided regarding the return of the actual complaint product to the manufacturer.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 15-jun-2018 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
Halyard received a single report that referenced three different incidents, which were associated with separate units, involving three different patients.This is the second of three reports.Refer to 3006646024-2018-00023 for the first patient.Refer to 3006646024-2018-00025 for the third patient.It was reported that several patients experienced a response of angioedema four or five weeks ago associated with the use of the mouth moisturizer.It was noted that there was no way of tracing the patients or determining their outcome or status.

• Brand Name: 24-HOUR ORAL CARE KIT WITH BALLARD TECHNOLOGY, Q4 WITH CHG
• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7605608
• Report Number: 3006646024-2018-00024
• Device Sequence Number: 19178308
• Product Code: JOL
• UDI-Device Identifier: 30680651139031
• UDI-Public: 30680651139031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 97014
• Device Catalogue Number: 991013903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/15/2018
• Patient Sequence Number: 1