MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE UNKNOWN ONQ PAINBUSTER PAIN RELIEF SYSTEM; UNKNOWN ONQ PUMP

Model Number UNKNOWN

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

Patient Problem Injury (2348)

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 21-nov-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc 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 avanos medical inc complaint database and identified as complaint comp-"xxx-xx-xxxxx".

Event Description

Fill volume: unknown, flow rate: unknown, procedure: ankle surgery, cath place: unknown.It was reported that a patient alleged injuries following placement of an onq painbuster pain relief system with an ankle surgery on (b)(6) 2017.No further information received.

Manufacturer Narrative

All information reasonably known as of 17-jan-2019 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 avanos medical inc 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 avanos medical inc.Avanos medical inc 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 avanos medical inc 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 an avanos medical inc product is defective or caused serious injury.

Event Description

During retrospective internal review, it was determined that this report is a duplicate of 2026095-2017-00048.Please see 2026095-2017-00048 for all further reporting on this event.

• Brand Name: UNKNOWN ONQ PAINBUSTER PAIN RELIEF SYSTEM
• Type of Device: UNKNOWN ONQ PUMP
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8096661
• MDR Text Key: 128120378
• Report Number: 2026095-2018-00153
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/23/2019
• Patient Sequence Number: 1