MAUDE Adverse Event Report: Q-MED AB7 DEFLUX; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Lot Number 11889-2

Device Problems Break (1069); Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

M.D.Was injecting and luer lock broke/exploded.Manufacturer response for deflux injectable gel syringe, (brand not provided) (per site reporter)
=
unknown.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): Q-MED AB7; 909 third ave; 27th fl.; new york NY 10022
• MDR Report Key: 4091638
• MDR Text Key: 4746670
• Report Number: 4091638
• Device Sequence Number: 1
• Product Code: LNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 11889-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2014
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 25