MAUDE Adverse Event Report: AVENT ON-Q PAIN RELIEF SYSTEM; ON-Q PAIN PUMP

Lot Number 0202688597

Device Problem Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 08/27/2017

Event Type  Injury  

Event Description

Ropivacaine 0.2% was administered via on-q pump to sciatic nerve after podiatry surgery.On left foot.I developed urinary incontinence and had to wear adult diapers.On second day, i removed the on-q pump.I reported to anesthesiologist on call because of severe incontinence.(b)(4).

• Brand Name: ON-Q PAIN RELIEF SYSTEM
• Type of Device: ON-Q PAIN PUMP
• Manufacturer (Section D): AVENT
• MDR Report Key: 6830703
• MDR Text Key: 84261213
• Report Number: MW5071852
• 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: 08/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2017
• Device Lot Number: 0202688597
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 91