MAUDE Adverse Event Report: INSULET CORPORATION PODPAL; ADHESIVE

Model Number 40201

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 07/21/2023

Event Type  Injury  

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.

Event Description

It was reported that a skin irritation causing a rash had occurred while wearing the pod and a podpal between 37 and 48 hours.Patient visited physician and was prescribed hydrocortisone cream 1% ointment.They were prescribed with a 15 gram tube to use every 3 days at each pod change.They used about 2-3 grams at each pod change.

• Brand Name: PODPAL
• Type of Device: 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: 18290090
• MDR Text Key: 330039584
• Report Number: 3004464228-2023-34603
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 40201
• Device Catalogue Number: POD-X9-000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male