MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Pain (1994); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 12/28/2021

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

Skin irritation causing permanent damage at the infusion site (abdomen) was reported.The patient observed a sore/knot, bleeding, pain, blisters, irritation, drainage, and permanent dark spots while wearing the pod.The patient has experienced this multiple times, and a doctor has advised the patient to stop using the product.The pod was removed.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• 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: 13196541
• MDR Text Key: 283757087
• Report Number: 3004464228-2022-00491
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2021

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: 19191
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/07/2022
• 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: 66 YR
• Patient Sex: Female