MAUDE Adverse Event Report: EMD SERONO, INC. EASY POD; INJECTOR, FLUID, NON-ELECTRICALLY POWERED

Model Number SW -REV R 4 5

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/21/2022

Event Type  Injury  

Event Description

I was told they had no more devices to inject my medication with.No warning just didn't make anymore.I take this medication for last 20 years (saizen) for my life and they said they didn't make another device.This is emd serano that the fda approved their easypod in the us.But apparently they let you pay huge amounts of money for their drug but don't have to warn you until you call for a replacement device that stopped working they no longer make the device and have no replacement for it.I will die without this medication because i cant make growth hormone in my body.I dont have the test because dr died.Fda safety report id# (b)(4).

• Brand Name: EASY POD
• Type of Device: INJECTOR, FLUID, NON-ELECTRICALLY POWERED
• Manufacturer (Section D): EMD SERONO, INC.; one technology place; rockland MA 02370
• MDR Report Key: 15174211
• MDR Text Key: 297468795
• Report Number: MW5111281
• Device Sequence Number: 1
• Product Code: KZE
• Combination Product (y/n): N
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SW -REV R 4 5
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALPHALIPOIC ACID ; ARMOUR THYROID 60 MG- 2 ; B12; B6; GLUCOSAMINE CHONDROTIN; MELATONIN 0.25 MG; SAIZEN 8.8 MG SAIZEN PREP- 3 ; SPIRONOLACTONE 50 MG-1 ; TUMERIC ; VIT C; ZINC
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White