MAUDE Adverse Event Report: BAUSCH + LOMB DEFLUX INJECTABLE GEL; AGENT, BULKING, INJECTABLE

Model Number DEFLUX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vomiting (2144); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

The consumer reported pain with urination and vomiting post deflux injection.Additional information was requested, but has not been received.

Manufacturer Narrative

The device was not returned to b+l for evaluation; therefore, product evaluation could not be conducted.The lot number of the device was not provided; therefore, a batch record review (brr)could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively determined.

• Brand Name: DEFLUX INJECTABLE GEL
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): Q-MED, SEMINARIEGATAN 21; q-med, seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5727394
• MDR Text Key: 47461200
• Report Number: 3009443653-2016-00009
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DEFLUX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other