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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE AVALON SMART TOCO+; SYSTEM, MONITORING, PERINATAL
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PHILIPS HEALTHCARE AVALON SMART TOCO+; SYSTEM, MONITORING, PERINATAL Back to Search Results
Model Number PN M2735A
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)
Event Date 03/04/2016
Event Type  malfunction  
Event Description
The rn noted that there were two red raised blistered areas forming a double ring on abdomen where toco had been.The pt denies pain, itching or irritation and didn't even know it was there.The pt reports it felt warm where toco had been but not hot enough to burn.The toco felt warm to touch.A physician was called to inform and md came to assess.The pt states no pain, itching or burning.The md instructs to wash area with soap and water and keep under observation.A different toco applied but washed thoroughly first and 4x4 gauze placed between skin and toco avoiding already irritated area.Initial toco sent to biomed.Phillips tocodynamometer.
 
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Brand Name
AVALON SMART TOCO+
Type of Device
SYSTEM, MONITORING, PERINATAL
Manufacturer (Section D)
PHILIPS HEALTHCARE
3000 minuteman road
andover MA 01810
MDR Report Key5825419
MDR Text Key50528652
Report Number5825419
Device Sequence Number1
Product Code HGM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Unknown
Device Model NumberPN M2735A
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2016
Event Location Hospital
Date Report to Manufacturer06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age35 YR
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