MAUDE Adverse Event Report: CDR SYSTEMS INC. INSTAFORM; PATIENT POSITIONNG FOAM MOULD KIT, ACCESSORY TO LINEAR ACCELERATOR

Model Number IFF03

Device Problem Improper or Incorrect Procedure or Method (2017)

Event Date 10/12/2022

Event Type  Injury  

Event Description

Contents of the bottle had been allowed to pressurize inside the closed container by the therapist (user).Components of container expanding per the normal process forcefully pushed the lid off and in what was described as a science experiment like volcanic eruption and sprayed into the therapist eyes and on some objects and surfaces of the room including the floor and ceiling.Therapist(user) subsequently it has been reported that the therapist (user) made an appointment with an ophthalmologist and was provided eye drops to help lubricate the eyes to mediate discomfort while her eyes heal from the injury.No long term damage has been reported only that the doctor is monitoring.

• Brand Name: INSTAFORM
• Type of Device: PATIENT POSITIONNG FOAM MOULD KIT, ACCESSORY TO LINEAR ACCELERATOR
• Manufacturer (Section D): CDR SYSTEMS INC.; 4334 - 110 ave se; calgary, alberta T2C0J 6; CA T2C0J6
• Manufacturer (Section G): CDR SYSTEMS; 4334 - 110 ave se; calgary, ab T2C 0 J6; CA T2C 0J6
• Manufacturer Contact: carl denis ; 4334 - 110 ave se; calgary, ab T2C 0-J6 ; CA T2C 0J6
• MDR Report Key: 15809137
• MDR Text Key: 303798905
• Report Number: 3009394603-2022-00001
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00628341930321
• UDI-Public: 00628341930321
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2023
• Device Model Number: IFF03
• Device Catalogue Number: IFF03
• Device Lot Number: 7-28D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other