MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE; FETAL SPIRAL ELECTRODE, SINGLE

Model Number 989803137631

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Serial number unknown.A follow-up report will be submitted once the investigation is complete.

Event Description

It was reported that a wound infection occurred after removal of the fetal scalp electrode.Medical intervention via the administration of antibiotics was required to treat the infection.

Manufacturer Narrative

The wound infection sustained after removal of the fetal scalp electrode was treated with antibiotics without further incident.As the fetal scalp electrode was not returned for analysis the cause of the reported issue could not be determined.The complaint will be tracked and trended.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9878581
• MDR Text Key: 185562569
• Report Number: 1218950-2020-01918
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 181449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 4