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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPODS

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INSULET CORPORATION OMNIPODS Back to Search Results
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.

 
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Brand NameOMNIPODS
Type of DeviceOMNIPODS
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key5913354
Report NumberMW5064417
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Report Date 08/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/26/2016 Patient Sequence Number: 1
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