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 Purulent Discharge (1812); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 07/20/2022

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 after wearing the pod on the leg for longer than 48 hours, the site was irritated, infected and purulent.The patient visited the walk in clinic, where was prescribed antibiotics (name unspecified) to be taken for 10 days.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16794890
• MDR Text Key: 313815206
• Report Number: 3004464228-2023-10271
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000112
• UDI-Public: (01)20385082000112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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: 04/17/2023
• 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 Age: 5 YR
• Patient Sex: Male