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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNPKNA
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 12/13/2018
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. This mdr is related to the retrospective review of complaints from companion medical inc, following medtronic¿s acquisition of the company in september 2020.
 
Event Description
Customer's parent reported indicated that the screw is not retracting at all. No harm requiring medical intervention was reported. The insulin pen will not be returned for analysis.
 
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Brand NameINPEN MMT-105NNPKNA NOVO NORDISK PINK
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer (Section G)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer Contact
neal grant
1223 world trade drive, 100
san diego, CA 92128
MDR Report Key11881559
MDR Text Key256804637
Report Number3012822846-2021-00271
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNPKNA
Device Catalogue NumberMMT-105NNPKNA
Device Lot NumberA92CC
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/10/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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