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

Model Number 989803196341

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Burning Sensation (4540)

Event Date 04/22/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the patches used with the avalon cl fetal & maternal pod caused burning of the patient's skin.

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
• Type of Device: 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
• MDR Text Key: 315567187
• Report Number: 1218950-2023-00347
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 20884838059324
• UDI-Public: 20884838059324
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803196341
• Device Catalogue Number: 989803196341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female