MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH, PODS 10-PACK; PUMP, INFUSION, INSULIN

Model Number PT-000029

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Skin Infection (4544)

Event Date 02/28/2023

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 customer's infusion site infection.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that a skin infection causing a rash and swelling had occurred while wearing the pod on the leg for longer than 48 hours.The patient was prescribed fucidin cream and an oral antibiotic amoxicillin (two times per day for 10 days) for treatment.The pod was discarded.

• Brand Name: OMNIPOD DASH, PODS 10-PACK
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16458783
• MDR Text Key: 310406976
• Report Number: 3004464228-2023-05806
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PT-000029
• Device Catalogue Number: POD-BLE-C1-529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female