MAUDE Adverse Event Report: ON Q PUMP; ON Q PAIN PUMP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 04/28/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, i went in for a cervical fusion, arthrodesis of occiput to c-1, c1-c2.Afterwards, they inserted an on q pain pump, immediately had to reinsert the ventilator because my throat swelled, and tongue was hanging out of my mouth.I've got a diagnosed latex allergy.The doctor was aware.He also said he called the company, but it wasn't stated in my records.He said they told him it contained latex, but wouldn't hurt me.If so, why did i swell immediately following the insertion of that pump with marcaine and ropivacaine.

• Brand Name: ON Q PUMP
• Type of Device: ON Q PAIN PUMP
• MDR Report Key: 4551597
• MDR Text Key: 5462642
• Report Number: MW5040928
• Device Sequence Number: 1
• Product Code: MEB
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: No
• Patient Sequence Number: 1
• Treatment: DILAUDID; ESTRADIOL; NORVASC; RX MEDS: SYNTHROID
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 46