MAUDE Adverse Event Report: INSULET CORPORATION PODPAL; ADHESIVE

Model Number	40201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Urticaria (2278); Skin Inflammation/ Irritation (4545)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the skin irritation.No lot release records were reviewed, as the product lot number was not provided.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneously reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6 per iso11135 and eo residual levels in compliance with iso10993.Each lot is confirmed to meet requirements for non-pyrogen city per iso10993 and sterility per iso11135 prior to release.*please note, that section d is capturing the device identifiers as reported by the complainant.This may not align to the device configuration reported in h11, as this data is pulled from our cloud based on the reported date of event.Cloud - locked down/smartphone lockdown cloud - omnipod 5 software app version 3.1.1 cloud - smartphone operating system n5004l-am-q-mv01602-06-01.06 cloud - smartphone hardware n5004l cloud - cgm sensor type g7.
Event or Problem Description
It was reported that a skin irritation causing itching, redness and an allergic reaction from the podpal being worn for 3 days.The patient reports they had gone to their doctors office where they were prescribed loratadine.The patient was at their doctors office for 1 hour.

• Brand Name: PODPAL
• Common Device Name: ADHESIVE
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 21876500
• Report Number: 3004464228-2025-17042
• Device Sequence Number: 7865257
• Product Code: KGX
• UDI-Device Identifier: 20385081120231
• UDI-Public: (01)20385081120231
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: Lay User/Patient
• Device Model Number: 40201
• Device Catalogue Number: POD-X9-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2025
• Initial Report FDA Received Date: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown