Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 60/17 PCC
  • 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
 

SILHOUETTE® PARADIGM®; COMFORT 60/17 PCC Back to Search Results
Lot Number INVALID
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.It was reported that while the patient was at his mother's house, sitting on the sofa and when was leaving, he noticed that the infusion set's tubing was hanging, as it came out of the plastic clear connector cap.This issue occurred with two infusion sets.The site location was at right side of patient's abdomen and the pump was worn on the right belt loop.One infusion set might had been in use for a day and other might had been lasted for a day.Reportedly, the infusions were stored on a table in a draw and one box on top of the table at room temperature.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Upon investigation performed on returned used device (8 tubing), it was found that the tubing was detached from the tubing connector.No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SILHOUETTE® PARADIGM®
Common Device Name
COMFORT 60/17 PCC
MDR Report Key9265208
Report Number8021545-2019-00141
Device Sequence Number13915868
Product Code FPA
UDI-Device Identifier05705244008755
UDI-Public05705244008755
Combination Product (Y/N)N
PMA/510(K) Number
K162812
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Lot NumberINVALID
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2019
Initial Report FDA Received Date11/01/2019
Patient Sequence Number1
-
-