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); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a persistent rash at the site where a pod pal adhesive had previously been applied to the leg.The patient reported redness of the skin that had not resolved and sought medical attention from an endocrinologist in (b)(6) 2026.The visit was noted as an outpatient visit, with no formal diagnosis provided.The healthcare professional prescribed an anti-inflammatory treatment; however, the patient did not obtain or use the prescribed medication and instead reported self-use of a non-prescribed topical agent (polysporin).No blood glucose levels were reported.No further information was provided.
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.We are unable to determine if any product condition could have contributed to the reported event.No lot release records were reviewed, as the product lot number was not provided.

• 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: 25630183
• Report Number: 3014585508-2026-39016
• Device Sequence Number: 12237858
• 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): 06/25/2026

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: 06/17/2026
• Initial Report FDA Received Date: 06/25/2026
• 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
• Patient Age: 52 YR
• Patient Sex: Female