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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ON-Q PUMP; PUMP, INFUSION, ELASTOMERIC

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AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ON-Q PUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Lot Number 20002966
Device Problem Leak/Splash (1354)
Patient Problem Inadequate Pain Relief (2388)
Event Date 02/27/2020
Event Type  malfunction  
Event Description
On q pump reported leaking by the patient's mother after discharge.Poor pain control reported with a need in treatment escalation.Mother reported event to manufacturer but did not receive a response regarding her concerns with the pump "leaking." mother reported difficulty navigating the manufacturer website to file the report.This report is being filed in response to a annual follow-up post therapy.Device was retained by patient's mother and is available for review.Fda safety report id#: (b)(4).
 
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Brand Name
ON-Q PUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
MDR Report Key11574535
MDR Text Key242792426
Report NumberMW5100290
Device Sequence Number1
Product Code MEB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number20002966
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/25/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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