OMNIPOD 5 POD
Report
- Report Number
- 3004464228-2022-03985
- Event Type
- Injury
- Date Received
- March 8, 2022
- Date of Event
- March 1, 2022
- Report Date
- March 1, 2022
- Manufacturer
- INSULET CORPORATION
- Product Code
- QFG
- PMA / PMN Number
- K203768
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
CORRECTION TO: D1 - BRAND NAME CHANGED FROM " " TO "OMNIPOD 5 POD". D2A - COMMON DEVICE NAME CHANGED FROM " " TO "ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP". D2B - PROCODE CHANGED FROM " " TO "QFG". D4 - CATALOG NO CHANGED FROM " " TO "POD-BLE-H1-520". G4 - PMA/510(K) # CHANGED FROM " " TO "K203768". H5 - LABELED FOR SINGLE USE CHANGED FROM "NONE SELECTED" TO "YES".
IT WAS REPORTED THAT SKIN IRRITATION CAUSING ITCHING, INFLAMMATION, SCALING, REDNESS, BRUISING, AND WATERY DISCHARGE HAD OCCURRED WHILE WEARING THE POD. THE AFFECTED AREA WAS THE SAME SIZE AS THE POD HARD OUTER SHELL. THE PATIENT VISITED A PHYSICIAN FOR 30 MINUTES AND WAS PRESCRIBED A STEROID CREAM BETAMETHASONE 15G, 0.05% TO BE APPLIED TO THE POD SITE DAILY FOR TWO WEEKS AFTER REMOVAL. THE POD WAS WORN TO THE APPOINTMENT. A NEW POD WAS APPLIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1324448 | OMNIPOD 5 POD | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | INSULET CORPORATION | PT-000435 | ||
| 1573266 | OMNIPOD 5 POD | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | INSULET CORPORATION | PT-000435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention |