MAUDE Adverse Event Report: BAUSCH + LOMB SOLESTA INJECTABLE GEL; AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE

Model Number SOLESTA

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

Patient Problems Fistula (1862); Pain (1994)

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 the patient developed rectal pain and a fistula adjacent to the injection site of solesta injectable gel approximately 1-2 years post injection.The fistula was reported to have leakage and the patient has continued to have problems with fecal incontinence.Additional information has been requested but has not been received.

Manufacturer Narrative

The product was not returned for evaluation and the lot number was not provided; therefore a dhr review could not be performed.Based on the current information the root cause of the event could not be conclusively determined.

• Brand Name: SOLESTA INJECTABLE GEL
• Type of Device: AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6153594
• MDR Text Key: 61694027
• Report Number: 3009443653-2016-00043
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

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: Health Professional
• Device Model Number: SOLESTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: 11/10/2016
• Supplement Dates FDA Received: 11/22/2017
• 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): Other