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

Model Number	IFF03
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3009394603-2022-00001
• Device Sequence Number: 7028263
• Product Code: IYE
• UDI-Device Identifier: 00628341930321
• UDI-Public: 00628341930321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown