MAUDE Adverse Event Report: PFIZER MANUFACTURING BELGIUM NV GENOTROPIN PEN DEVICE 12 MG; INJECTOR, PEN

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
My son used norditropin for growth hormone deficiency.There is currently a national shortage of this drug so we were told to go with genotropin.I have contacted pfizer numerous times (3.5 to 4 hour hold time) to get the prescription.The genotropin will be delivered today however there is also a national shortage for the pen device which is needed to administer the drug.In the process of getting the drug, pfizer did not tell me i also needed a prescription for the pen device, so i am starting the whole process over with my son's doctor.In contacting pfizer they have no idea when a pen device will be available which will result in my son not being able to get his medication.

• Brand Name: GENOTROPIN PEN DEVICE 12 MG
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): PFIZER MANUFACTURING BELGIUM NV; genotropin pen device 12 mg
• MDR Report Key: 16502113
• Report Number: MW5115509
• Device Sequence Number: 14024126
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENOTROPIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 36 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White