MAUDE Adverse Event Report: SALIX PHARMACEUTICAL SOLESTA 50MG/ML

Device Problem Positioning Problem (3009)

Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091); Fluid Discharge (2686)

Event Date 08/01/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 i received 4 solesta injections of one milliliter each into my anal canal for the treatment of fecal incontinence.The injection on the midline of the anterior wall was very painful and it had bled profusely after the injection.The surgeon performing the treatment had to apply pressure to the site.Immediately after the procedure i started experiencing rectal pressure, anal itching and a mucous discharge from my rectum.After a day or so post-treatment i noticed a bulge in my vagina the size of an egg.I called the surgeon and was told that it could be a hematoma and that it would resolve.On (b)(6) 2013 i contacted salix pharmaceutical inc, the company that produces solesta, and reported my symptoms.Soon after they sent me a form in the mail and a medical release to contact my surgeon.The pharmaceutical company gave me a case number, (b)(4).On (b)(6) 2013 i was examined by the surgeon in his office and was told that most likely it was a hematoma that would resolve.I went back for follow-up to this surgeon 3 more times in the course of 3-4 months.My last visit with him was in (b)(6) and was told that he believed the injection substance had gone into my vagina and formed the mass which by now was bigger and bothersome and it should be excised and to schedule a surgical date with his office.I have since sought a second opinion by a urogynecologist who wants to have an mri done before any surgery is scheduled because the high risk for a fistula to form between the vagina and the rectum.At the time the vaginal mass from this solesta injection is 4 x 4 centimeters and is putting a big pressure in my vagina.I am very concerned with this issue which was caused by this injection.During my last visit in (b)(6) with the surgeon who did the procedure he told me that the pharmaceutical company had contacted him and that the pharmaceutical company was thinking about putting a stopper in the syringe.He also told me that "he may have gone in too deep." i did extensive research on this product prior to having the treatment and nowhere in their package insert was this adverse event listed.At this time i am facing surgery to correct this adverse event and i do not know if there will be permanent and long lasting sequelae as a result of this injection and the procedure.

• Brand Name: SOLESTA 50MG/ML
• Type of Device: SOLESTA
• Manufacturer (Section D): SALIX PHARMACEUTICAL
• MDR Report Key: 3639498
• MDR Text Key: 4202754
• Report Number: MW5034607
• 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: 02/13/2014

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: Other
• Other Device ID Number: B90-13519-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 73