MAUDE Adverse Event Report: SALIX SOLESTA; NONE

Device Problem Insufficient Information (3190)

Patient Problem Constipation (3274)

Event Date 11/12/2014

Event Type  Injury  

Event Description

Dose or amount: 4cc in four 1 cc units.Frequency: one time.Route: rectal.Diagnosis or reason for use: fecal incontinence following (b)(6) 2013 sphincterotomy.Event abated after use stopped or dose reduced: no.After receiving an injection of solesta, i developed extreme constipation and an inability to empty my bowels.I had no constipation before, either immediately or in the past.The administering physician did not believe this to be a side-effect of solesta, and recommended a laxative, but the adverse affects have persisted now for eight days.The prescribing info for solesta, which i found online, warned not to take an enema for one month after injection of the gel, though the physician has identified an enema as the only alternative treatment of the symptoms i am presenting.

• Brand Name: SOLESTA
• Type of Device: NONE
• Manufacturer (Section D): SALIX; * ; *
• MDR Report Key: 4284339
• MDR Text Key: 22033635
• Report Number: MW5039292
• Device Sequence Number: 1
• Product Code: LNM
• 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: 11/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR