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

MAUDE Adverse Event Report: THERATECHNOLOGIES INC. 1MG SYRINGE SYRINGE, PISTON

  • 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
 

THERATECHNOLOGIES INC. 1MG SYRINGE SYRINGE, PISTON Back to Search Results
Device Problems Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Pt states that approximately 6 months ago she began having complications with the injection box for egrifta. Pt reports that the manufacturer has recently changed the height of mixing needle from an 18 gauge 1. 5 inch needle to a thinner 20 gauge 1 inch needle which has prevented her from mixing and extracting her medication. Pt states that the shorter needle now requires her to hold the bottle upside while she injects the mixing needle into the vial and prepares the medication. Pt reports that due to issues with her vision and trouble with hand eye coordination, that she cannot utilize the shorter needles and was unable to administer the medication. Secondly pt states that syringes have changed from 3 mg to 1 mg and the smaller diameter of the new syringes allows for more air bubbles that are difficult to remove which also prevent her from obtaining correct amount of water for dilution. Pt also reports that the mixing needle is now detached from the syringes and requires the consumer to attach the needle which she notes is time consuming. Additionally, pt reports that she receives 60 1 mg syringes for a 30 day supply and notes safety concern that the extra discarded syringes can end up in the wrong hands as well as unnecessary medical waste caused by excessive supply. Pt also notes that because she was unable to use the new 20 gauge needles she now received a 30 day supply of the 18 gauge needles from her pharmacy and throws all 60 of the 20 gauge mixing needles she receives from the injection box which also is cause for concern to due to medical waste. Pt reports that medication is costly and that the changes made to the injection box have made the user experience for medication administration more difficult. Of note, pt states that she has contacted the manufacturer who have alleged that they cannot do anything to help the pt with her issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name1MG SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
THERATECHNOLOGIES INC.
MDR Report Key12161583
MDR Text Key261722872
Report NumberMW5102518
Device Sequence Number2
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/12/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received07/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

-
-