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

Model Number 989803196341

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that a layer of skin was removed when the clinicians removed the patch from that patient's abdomen.

Manufacturer Narrative

A philips clinical application specialist (cas) remotely interviewed the customer who was onsite.The cas confirmed with the customer the patch was chosen based to patients bmi of 48 ¿ weight 126 kg.The patient stated that she has sensitive skin, but not as significant an allergy/reaction as this one.A clinical consultant did not provide the skin preparation, but the customer was provided education on how to administer.The adhesive make up was unknown.Prior to applying the patch, there were no lotions or oils on the patient's skin.The skin was prepared with plain warm water, face wash, and dried after.The patient's abdomen was prewashed/wiped with warm water and towel and dried.The skin was prepared with 3m red dot trace prep where pod patches were to go by swiping 3 times vertically and 3 times horizontally.The patient laid semi recumbent on the bed for application.The patient peeled the patches off themselves with no adhesive removers or other products.When the event occurred, the customer was administering fetal monitoring for induction of labour on the patient.The patches were on the patient for 5 hours.The skin reaction's appearance was prickly red rash, painful and sensitive to touch.The skin was lifted in some areas, notably with the middle patch.The patient was prescribed antihistamines for the rash.Based on the information available, the cause of the reported problem was unconfirmed.We were informed by the customer that the device was discarded and was not available for evaluation.Without the material being returned, we are not able to perform an evaluation to determine the cause of the reported incident.Based on the information available and results of additional analysis, no further action is necessary at this time.H3 other text : device was discarded.

• 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: 17286951
• MDR Text Key: 318785644
• Report Number: 1218950-2023-00477
• Device Sequence Number: 1
• Product Code: OSP
• UDI-Device Identifier: 20884838059324
• UDI-Public: 20884838059324
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2023
• 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
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 126 KG