MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS TALTZ PF AUTOINJ (1-PAK); INJECTOR, PEN

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Call from reimbursement specialist (b)(6) calling due to patient having faulty first order.Lot number and expiration date unknown.Unknown if patient experienced an adverse event due to the defective product.Unknown if patient has the product on- hand or if missed dose.No other information.Direction: 80mg sq every 2 weeks (weeks 8 and 10).Reported to (b)(6) by: patient/caregiver; health professional.

• Brand Name: TALTZ PF AUTOINJ (1-PAK)
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS; lilly corporate center drop code 1084 ; indianapolis IN 46285
• MDR Report Key: 10958692
• MDR Text Key: 220246288
• Report Number: MW5098230
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2020

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2020
• Patient Sequence Number: 1