MAUDE Adverse Event Report: SOLESTA; NONE

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Prolapse (2475)

Event Date 03/13/2014

Event Type  Injury  

Event Description

My mother received a treatment of solesta for anal incontinence on (b)(6).My father then took my mother to her post procedural check up and mentioned to the physician that there was a rectal prolapse, that would require a procedure such as "tacking the colon back up", or resecting the colon, or a colostomy.My father wasn't ready to make that decision immediately but now her rectum has prolapsed 3-4 inches, she was in a lot of pain, and has intermittent bleeding (she is on blood thinners), follow up with the doctor is on monday to have a procedure scheduled later in the week hopefully.Date of use: (b)(6) 2013.Diagnosis: anal incontinence.

• Brand Name: SOLESTA
• Type of Device: NONE
• MDR Report Key: 3695322
• MDR Text Key: 4245370
• Report Number: MW5035077
• Device Sequence Number: 1
• Product Code: LNM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR