MAUDE Adverse Event Report: SHIRE HUMAN GENETIC THERAPIES, INC. GATTEX ANCILLARY SUPPLY; SYRINGE, PISTON

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

Patient's family spontaneously reported that they were missing supplies in the gattex ancillary supply kit.The kit did not have sufficient needles for the 30 day supply of gattex that was shipped.The kit was missing 3 needles (the 22g screw on needle).No additional information available at this time.Indication: postsurgical malabsorption, not elsewhere classified.Reported to (b)(6) by pt/caregiver.

• Brand Name: GATTEX ANCILLARY SUPPLY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): SHIRE HUMAN GENETIC THERAPIES, INC.
• MDR Report Key: 11071921
• MDR Text Key: 223738416
• Report Number: MW5098520
• Device Sequence Number: 1
• Product Code: FMF
• 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: 12/14/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Patient Sequence Number: 1