MAUDE Adverse Event Report: VALEANT PHARMACEUTICALS, INC DEFLUX INJECTABLE GEL; AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE

Model Number DEFLUX INJECTABLE GEL

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Fever (1858)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that a deflux patient was hospitalized due to fever and pain in the lower abdomen.The location of the deflux injection (2 ml dose) had been at the right ureter.The physician initially suspected a urinary tract infection, but due to the patient's worsening condition, an ovarian abscess was then thought to be the cause of the pain.A ct scan and gynecological consultation (with laparoscopy) were performed.Abscess was not confirmed.A laparotomy on the patient finally revealed a funnel-shaped abscess at the deflux injection site.A second ct scan also confirmed the presence of an abscess in the right abdomen, close to the ovary and the right ureter opening.After discovery, the abscess was then surgically removed.After the removal, the physician suspected that the patient may have experienced an allergic reaction to the deflux gel.Thus, the product was not re-introduced into the patient.Additional information has been requested but has not been received.

Manufacturer Narrative

Investigation of this event is still in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was stated that a ureter stent was also surgically removed from the patient, along with the abscess.Post-surgery, the patient is said to be very satisfied.

Manufacturer Narrative

The device was not available for evaluation.The device lot number was not provided; however, the device history records of 4 lot numbers that had been delivered to the customer were reviewed.For each of the four batches, all microbiological and chemical test results were within specification limits.The environmental tests are approved.The sterilization process were determined to be according to the sterilization specification.There were no non-conformities to affect the quality of the product.No potential quality issues have been identified in the manufacturing process.The volume of complaints is within the acceptable control limits and no complaint trend is observed.Based on the available information, a root cause of the reported event could not be determined.

• Brand Name: DEFLUX INJECTABLE GEL
• Type of Device: AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): VALEANT PHARMACEUTICALS, INC; rochester NY 14609
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala SE-75 2 28; SW SE-752 28
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6300262
• MDR Text Key: 66470488
• Report Number: 3009443653-2017-00004
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DEFLUX INJECTABLE GEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided; 10/16/2017
• Supplement Dates FDA Received: 05/19/2017; 11/14/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 46 YR