MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL FETAL & MATERNAL POD; MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Model Number	AVALON CL FETAL & MATERNAL POD
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient developed a skin reaction under the patches of the beltless solution.Per the provided picture, a crust or scab formed in a circular pattern where the patches were applied.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Additional review of the record was performed, revealing the original customer feedback form categorized the harm as 'temporary or reversible harm to a person (not requiring additional medical intervention)'.Based on this information, the harm was not life threatening, did not result in permanent damage/impairment, and did not require medical or surgical intervention; therefore, the event does not meet criteria for serious injury.No analysis was performed.The midwife was trained on how to apply the patch to the mother.Attempts were made to reach the customer for additional information however, the customer did not respond.The investigation found that the product was confirmed to be operating per specifications, and the cause of the reported problem was that the customer required training.The issue was resolved by training on how to apply the patch to the mother.A review of the service history for this device shows the problem has not been reported again for this device.

• Brand Name: AVALON CL FETAL & MATERNAL POD
• Common Device Name: MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 23826566
• Report Number: 9610816-2025-001240
• Device Sequence Number: 13019328
• Product Code: HFM
• UDI-Device Identifier: 00884838068179
• UDI-Public: (01)00884838068179
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: AVALON CL FETAL & MATERNAL POD
• Device Catalogue Number: 866488
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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: Other
• Patient Sex: Female