• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN POD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INSULET CORPORATION OMNIPOD INSULIN POD Back to Search Results
Lot Number L41897
Event Date 10/10/2015
Event Type  Malfunction  
Event Description

Our son has an omnipod insulin pump. He has had 3 pods that failed to deploy the needle and insert, but when deactivated and taken off and set down with a little jolt all three deployed after removal. First 2 pods were on (b)(6) 2015, the 3rd was (b)(6) 2015.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMNIPOD INSULIN POD
Type of DeviceOMNIPOD INSULIN POD
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key5207721
Report NumberMW5057709
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Report Date 11/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/03/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date01/01/2017
Device LOT NumberL41897
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

-
-