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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM INFUSION SET

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UNOMEDICAL A/S SILHOUETTE PARADIGM INFUSION SET Back to Search Results
Model Number MMT-377
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
The claimed failure cannot be confirmed. No failure reported. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). A diabetic patient on pump therapy passed away. Date unknown. The incident was reported by a friend of patient when she called to ask if patient's infusion sets (lot number) were apart of the recall inquired what led up to the complaint. She was advised that the lot number was not a part of recall. She mentioned that she did not have the details surrounding the patient's death. No further information available.
 
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Brand NameSILHOUETTE PARADIGM INFUSION SET
Type of DeviceSILHOUETTE PARADIGM
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
0458167000
MDR Report Key7230158
MDR Text Key98641623
Report Number8021545-2018-00003
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2020
Device Model NumberMMT-377
Device Lot Number5184757
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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