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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Pain (1994); Hematuria (2558)

Event Date 05/21/2015

Event Type  Injury  

Event Description

It was reported that the pt received a solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal.Metronidazole was administered as prophylaxis two days prior and two days post solesta injection.One day following the injection, the pt complained of pain, diarrhea and blood in the urine.

Manufacturer Narrative

The event investigation is underway, the results will be provided in a f/u report.

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.Placeholder.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): SALIX PHARMACEUTICALS, INC; raleigh NC
• Manufacturer (Section G): Q-MED AB; q-med ab, seminariegatan 21; upssala ; SW
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4861517
• MDR Text Key: 5850587
• Report Number: 3009325614-2015-00029
• 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: Distributor
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR