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 Codes	Swelling (2091); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: no code (tongue swelling).The actual complaint product was not returned for evaluation.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 31-may-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).The device was not returned.
Event or Problem Description
Halyard received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the first of four reports.Refer to 3006646024-2018-00020 for the second event.Refer to 3006646024-2018-00021 for the third event.Refer to 3006646024-2018-00022 for the fourth event.The patient experienced tongue swelling after using the oral care kit.The clinicians stopped using the kit.It was reported the swelling was better after the oral care kit was no longer used.The kits were only identified for common treatment across all the affected patients in which the symptoms were attributable.

• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7560839
• Report Number: 3006646024-2018-00019
• Device Sequence Number: 177467
• Product Code: JOL
• UDI-Device Identifier: 30680651139031
• UDI-Public: 30680651139031
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/10/2018

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: Nurse
• Device Model Number: 97014
• Device Catalogue Number: 991013903
• 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: 05/10/2018
• Initial Report FDA Received Date: 06/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 66