MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FETAL SPIRAL ELECTRODE

Model Number 989803137631

Device Problem Device Handling Problem (3265)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Based on the investigation, there is insufficient data available to determine the actual cause of the incident.The patient is reported to be at home with no more issues.Device discrded.

Event Description

It was reported to philips that the fetal scalp electrode (fse) has remained embedded in the baby's scalp on removal of the electrode.The lodged piece was removed and a wound dressing was applied.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12475700
• MDR Text Key: 271516615
• Report Number: 1218950-2021-10920
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 214092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other