MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE

Model Number 989803137631

Device Problem Material Fragmentation (1261)

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the fse caused a small scab at birth and ultrasound reveled a small piece of the wire was retained.No infection was noted.The small piece remains and will be removed in 5-6 months.

Event Description

The customer reported the fse caused a small scab at birth and ultrasound reveled a small piece of the wire was retained.No infection was noted.The small piece remains and will be removed in 5-6 months.

Manufacturer Narrative

The customer stated that they device was discarded and will not be able to be retuned for evaluation.If additional information is later obtained, the complaint will be reopened.The customer sated that the patient has not returned to the hospital with any issues.No further actions were taken and none are warranted.

Event Description

The customer reported the fse caused a small scab at birth and ultrasound reveled a small piece of the wire was retained.No infection was noted.The small piece remains and will be removed in 5-6months.

Manufacturer Narrative

This supplemental report is created with reference to mfg report #1218950-2021-10765 with corrected information to update the manufacturing site.H3 other text : the customer stated that they device was discarded.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12246388
• MDR Text Key: 264093269
• Report Number: 1218950-2021-10765
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 213974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• 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