MAUDE Adverse Event Report: HAYLARD HEALTH/AVANOS MEDICAL, INC ON-Q PAIN RELIEF SYSTEM; PUMP, INFUSION, ELASTOMERIC

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

Patient Problems Dysphagia/ Odynophagia (1815); Fainting (1847); Fever (1858); Nausea (1970); Tinnitus (2103); Vomiting (2144); Chills (2191); Dizziness (2194); Patient Problem/Medical Problem (2688)

Event Date 12/03/2018

Event Type  Injury  

Event Description

Patient had on -q pain relief system placed post hip replacement.She recalls being unable to administer the medication herself.In the evening the patient experienced symptoms such as fever, ¿very bad¿ chills, bladder loss, difficulty swallowing, dizziness, lightheadedness, ringing in ears, taste of metal, loss of appetite, nausea and vomiting.The patient notes.She fainted twice the next day.She was not familiar with this product and was unaware of its placement.

• Brand Name: ON-Q PAIN RELIEF SYSTEM
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HAYLARD HEALTH/AVANOS MEDICAL, INC
• MDR Report Key: 8174301
• MDR Text Key: 131006500
• Report Number: MW5082184
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/17/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR