MAUDE Adverse Event Report: MEDIMOP MEDICAL PROJECTS, LTD. MEDIMOP 20MM VIAL ADAPTER

Model Number 8072004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 10/18/2014

Event Type  Death  

Event Description

A pharmacist reported via an (b)(4) sales representative that a (b)(6) year old female patient started abilify maintena (aripiprazole) 400 mg, frequency unknown on an unknown date for schizophrenia.She also started carbamazepine, unknown dose and frequency on an unknown date for schizophrenia.The patient has no relevant medical history.The patient's relevant concomitant medications and past drug history are unknown.The patient was prescribed both medications by a provider she was seeing on an out-patient basis at a hospital.On (b)(6) 2014, sometime after her third injection, she was admitted to a different psychiatric hospital for breakthrough symptoms.The pharmacist realized that the patient had been taking the abilify maintena and the carbamazepine together and should not have been.She was discontinued from the carbamazepine.On (b)(6) 2014, at 5 pm, she received her 4th injection of the abilify maintena while still in the psychiatric hospital.At 5 am, on (b)(6) 2014, she had a pulmonary emboli and was rushed to a medical hospital, at 7 am on (b)(6) 2014, she passed away.

Manufacturer Narrative

The medimop vial adapter device is packaged with (b)(4)'s drug product.The device associated with this event was not returned to medimop for further investigation and no additional information has been received.Medimop has completed an internal investigation which found nothing to support any correlation between the incident and the device.There have been no other related or similar complaints associated for the device lot in question.Medimop will send a supplemental mdr if any additional information regarding this event is obtained.

• Brand Name: MEDIMOP 20MM VIAL ADAPTER
• Type of Device: VIAL ADAPTER
• Manufacturer (Section D): MEDIMOP MEDICAL PROJECTS, LTD.; 17 hatidhar st.; p.o. box 2499; raanana 4366 519; IS 4366519
• Manufacturer Contact: 17 hatidhar st.; p.o. box 2499; raanana 43665-19 ; 097778666
• MDR Report Key: 4336973
• MDR Text Key: 5219018
• Report Number: 3000223297-2014-00001
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8072004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABILIFY MAINTENA
• Patient Outcome(s): Death
• Patient Age: 23 YR