MAUDE Adverse Event Report: INSULET CORPORATION OMNIPODS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Pain (1994); Skin Erosion (2075); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 08/18/2016

Event Type  Injury  

Event Description

Caller advised her daughter had the omnipod inserted in her left arm and sometime last week her daughter complained of pain.Upon examination of the left arm, a burn was noticed characteristic of second degree, swelling, skin erosion and crusty skin were present as well.A home nurse visited and they used a new omnipod.The skin was prepped before the omnipod was placed.On (b)(6) 2016, she took her daughter to see her physician who diagnosed cellulitis and cortisone ointment was prescribed.Caller already reported to mfr about side effect and was informed that 2 percent of users suffer from side effects.She wants other users to be aware of this negative side effect.

• Brand Name: OMNIPODS
• Type of Device: OMNIPODS
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 5913354
• MDR Text Key: 53579974
• Report Number: MW5064417
• Device Sequence Number: 1
• Product Code: LZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/26/2016

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 44