MAUDE Adverse Event Report: SALIX SOLESTA; GEL

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 08/06/2014

Event Type  Injury  

Event Description

Pt admitted to hospital with sepsis within 24 hrs of solesta injection for fecal incontinence.Dose or amount: 1cc x 4 injections.

• Brand Name: SOLESTA
• Type of Device: GEL
• Manufacturer (Section D): SALIX
• MDR Report Key: 4025109
• MDR Text Key: 4845650
• Report Number: MW5037807
• 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: Physician
• Type of Report: Initial
• Report Date: 08/08/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2014
• Patient Sequence Number: 1
• Treatment: LOPERAMIDE; FUROSEMIDE; VITRON-C; GLUCOSAMINE-CHONDROITIN; CARVEDILOL; METFORMIN; ZETIA; CRESTOR
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Weight: 81