MAUDE Adverse Event Report: CAREFUSION FINLAND 320 OY VITAL SIGNS; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Model Number	7000AAO
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The physician noted and she had to pull this through the uterus attached to the fetal scalp and was unable to remove it prior to the surgery.During labor she had placed a second one, and referred to the one she could not remove as the "extra fse." it is unclear who removed it after delivery based on documentation.

• Brand Name: VITAL SIGNS
• Common Device Name: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): CAREFUSION FINLAND 320 OY; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 12048885
• Report Number: 12048885
• Device Sequence Number: 3565560
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/07/2021
• Report Date (Section F): 06/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 7000AAO
• Device Catalogue Number: 7000AAO
• Device Lot Number: S13191-F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Date Report Sent to FDA: 06/07/2021