MAUDE Adverse Event Report: SALIX PHARMACEUTICALS, INC SOLESTA; AGENT, BULKING, INJECTABLE

Model Number 182694

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Chills (2191); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

The event investigation is underway; a follow up report will be submitted upon completion of investigation.

Event Description

It was reported that one to two days following fecal incontinence treatment, the patient developed fever, chills, and pain at the injection site.The patient was diagnosed with an infection and was treated with cephalexin, tramadol and flagyl and the symptoms improved.Approximately two weeks post treatment the patient developed severe pain exacerbated by defecation and bleeding.The patient was prescribed delotta and anusol.Five weeks post treatment, the patient reported to be doing well.

Manufacturer Narrative

The product was not returned for evaluation; therefore, product evaluation could not be conducted.The lot number of the product was not provided; therefore, a batch record review (brr) could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively determined.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): SALIX PHARMACEUTICALS, INC; raleigh NC 72615
• Manufacturer (Section G): Q-MED AB; q-med ab, seminariegatan 21; upssala 75228 ; SW 75228
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5079665
• MDR Text Key: 25878923
• Report Number: 3009325614-2015-00030
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 182694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• 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
• Patient Age: 31 YR