MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS MEDICAL TOCO+ MP; MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Device Problem Device Fell (4014)

Patient Problem Reaction (2414)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Plastic covering fell off to monitoring device causing skin reaction to abdomen.Fda safety report id# (b)(4).

• Brand Name: PHILIPS MEDICAL TOCO+ MP
• Type of Device: MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 10755041
• MDR Text Key: 213886329
• Report Number: MW5097519
• Device Sequence Number: 1
• Product Code: HFM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR