MAUDE Adverse Event Report: SYRINGE; SYRINGE, PISTON

Patient Problems Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Date 11/22/2023

Event Type  Injury  

Event Description

The reporter called regarding syringe which was introduced into patient's gluteus maximus muscle has developed into a pimple like structure.The reporter had to visit the emergency room for left brow injury on (b)(6) 2024.He pinched the pimple like structure and a small amount of drain came out.

• Brand Name: SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 18778276
• MDR Text Key: 336254925
• Report Number: MW5151931
• Device Sequence Number: 1
• Product Code: FMF
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 91 KG