MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON CL FETAL & MATERNAL PATCH

Model Number	989803196341
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the patches used with the avalon cl fetal & maternal pod caused burning of the patient's skin.
Additional Manufacturer Narrative
This report is based on information provided by our philips complaint handling team.Philips received a complaint on april 11, 2023, regarding the avalon cl fetal & maternal patch lot unspecified indicating that the patient reported burning and discomfort when the nurse removed the patch.The actual patches were not made available for evaluation to determine the actual cause of the reported incident.It was advised that a first step prior to usage of the product is to discuss skin sensitivity with the patient to assess patient eligibility for usage with the product.Red marks are to be expected per product specifications.It was also advised that any patch removal be conducted slowly and at a low angle to reduce skin damage and irritation as a precaution.

• Brand Name: AVALON CL FETAL & MATERNAL PATCH
• Common Device Name: AVALON CL FETAL & MATERNAL PATCH
• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16962414
• Report Number: 1218950-2023-00347
• Device Sequence Number: 14761892
• Product Code: HGM
• UDI-Device Identifier: 20884838059324
• UDI-Public: 20884838059324
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Model Number: 989803196341
• Device Catalogue Number: 989803196341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female