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

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.

• Brand Name: 1MG SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): THERATECHNOLOGIES INC.
• MDR Report Key: 12161583
• MDR Text Key: 261722872
• Report Number: MW5102518
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1