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

Model Number	FETAL SPIRAL ELECTRODE
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This supplemental report is created with reference to mfg report #1218950-2021-10766 with corrected information to update the registered legal manufacturing site.
Event or Problem Description
It was reported to philips that the baby developed localized infection at fse site.

• Brand Name: FETAL SPIRAL ELECTRODE
• Common Device Name: 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13925171
• Report Number: 1218950-2022-00257
• Device Sequence Number: 6357208
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: FETAL SPIRAL ELECTRODE
• Device Catalogue Number: 989803137631
• Device Lot Number: 213974
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 3 KG