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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE PARADIGM UNO COMFORT 60/17 SC1 MINI

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SILHOUETTE PARADIGM UNO COMFORT 60/17 SC1 MINI Back to Search Results
Model Number MMT-378A
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On (b)(6) 2021, the patient's wife reported that the infusion set's tubing had detached at the site. Reportedly, it detached the whole set even the tape area. The site location was the patient's abdomen and the infusion had been used for a few hours. Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity. Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body. No further information available.
 
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Brand NameSILHOUETTE PARADIGM
Type of DeviceUNO COMFORT 60/17 SC1 MINI
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key11997474
MDR Text Key256162479
Report Number8021545-2021-00124
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-378A
Device Lot Number5305122
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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