MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN; ELASTOMERIC LFR

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.Root cause could not be determined.All information reasonably known as of 25-apr-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 (b)(4) 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 (b)(4).(b)(4) 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 (b)(4) complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a (b)(4) product is defective or caused serious injury.Device not returned.

Event Description

(b)(4) received a single report regarding a professional literature publication, journal of pediatric surgery 51 (2016) pages 154¿158, that referenced 13 different incidences, which were associated with separate units.This is the twelfth of 13 reports.Refer to 2026095-2017-00065 for the first incident.Refer to 2026095-2017-00066 for the second incident.Refer to 2026095-2017-00067 for the third incident.Refer to 2026095-2017-00068 for the fourth incident.Refer to 2026095-2017-00069 for the fifth incident.Refer to 2026095-2017-00070 for the sixth incident.Refer to 2026095-2017-00071 for the seventh incident.Refer to 2026095-2017-00072 for the eighth incident.Refer to 2026095-2017-00073 for the ninth incident.Refer to 2026095-2017-00074 for the tenth incident.Refer to 2026095-2017-00075 for the eleventh incident.Refer to 2026095-2017-00077 for the thirteenth incident.The article states: 1) "patients treated with a peri-incisional on-q (i-flow, kimberly-clark, irvine, ca) also had higher infection rates (8.3% vs 2.4%, p <.001)." 2) "total of 156 patients were treated with a peri-incisional on-q (i-flow, kimberly-clark, irvine, ca) at our facility.Thirteen of those patients (8.3%) developed an infection which is significantly higher than the infection rate observed in patients who did not receive an on-q (2.4%);" no additional information was provided.

• Brand Name: UNKNOWN
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6530901
• MDR Text Key: 74009207
• Report Number: 2026095-2017-00076
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2017

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
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/28/2017
• 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