MAUDE Adverse Event Report: INSULET CORPORATION PODPAL; ADHESIVE

Model Number	40201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.No lot release records were reviewed, as the product lot number was not provided.We are unable to determine if any product condition could have contributed to the reported event.
Event or Problem Description
A legal guardian (lg) reported that the patient experienced an alleged allergic skin reaction associated with use of a podpal adhesive while wearing a pod.The patient had been wearing the pod on the leg for an unknown duration of use.The event was reported retrospectively and was stated to have occurred in early june 2025.According to the lg, use of the podpal resulted in skin irritation characterized by redness and inflammation.The patient sought medical attention on (b)(6) 2025 during a routine healthcare provider appointment, during which the skin reaction was observed and discussed.The pod and podpal had been removed prior to the appointment due to discomfort during removal.No pod was worn at the time medical attention was sought.The healthcare provider prescribed topical treatment (triamcinolone acetonide cream).The diagnosis specific to the event was documented as an allergic reaction to adhesive.

• 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 25416950
• Report Number: 3014585508-2026-33286
• Device Sequence Number: 13165225
• Product Code: KGX
• UDI-Device Identifier: 20385081120231
• UDI-Public: (01)20385081120231
• Combination Product (Y/N): N
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 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: 05/07/2026
• Initial Report FDA Received Date: 06/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female