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); Skin Inflammation/ Irritation (4545)
Date of Event	06/05/2024
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 required.
Event or Problem Description
It was reported that the patient experienced skin irritation when wearing podpals between 25 and 36 hours.The patient said the pods do not cause irritation, only when they wear the podpals.They went to a doctor was prescribed skin protection novatech smta, a dry wash cream to administer twice a week and an anti-adhesive, laboratoire gilbert, every time they apply a new pod.

• 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: 19482559
• Report Number: 3004464228-2024-21016
• Device Sequence Number: 8010637
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 06/05/2024
• Initial Report FDA Received Date: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female