MAUDE Adverse Event Report: HALYARD - IRVINE HALYARD* ON-Q PUMP KITS WITH ON-Q SILVERSOAKER; ELASTOMERIC LFR

Model Number	PM028-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.All information reasonably known as of 26-oct-2017 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.(b)(4).
Event or Problem Description
Procedure: hemorrhoidectomy.It was reported that a patient developed an abscess while using the on-q.The patient developed an abscess post hemorrhoidectomy at the insertion site of the on-q.The hemorrhoidectomy wound was clean and not affected as the pus pocket remained lateral with normal skin between the two areas.No additional information was provided.

• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6983268
• Report Number: 2026095-2017-00187
• Device Sequence Number: 684126
• Product Code: MEB
• UDI-Device Identifier: 30680651137211
• UDI-Public: 30680651137211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2017

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?: No
• Operator of Device: Physician
• Device Model Number: PM028-A
• Device Catalogue Number: 101372100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other