MAUDE Adverse Event Report: Q-MED AB SOLESTA; AGENT, BULKING, INJECTABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Sepsis (2067)

Event Date 04/01/2014

Event Type  Injury  

Event Description

A physician reported via a sales rep that an elderly male pt received solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal as treatment for fecal incontinence.Additional medical history and concurrent medications were not provided.On (b)(6) 2014, the pt received solesta, on an unk date the pt developed septic escherichia coli and a high fever, requiring hospitalization.Hospital course and treatment were not provided.On an unk date, the events resolved.Causality was not reported.The company assessed the events as possibly related to solesta.

Manufacturer Narrative

Based on the info a causality seems possible.No batch analysis could be performed since info about batch number is missing.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer Contact: 8510 colonnade center dr; product safety; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3847070
• MDR Text Key: 4684507
• Report Number: 3009325614-2014-00027
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2014,04/29/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2014
• Distributor Facility Aware Date: 04/29/2014
• Date Report to Manufacturer: 05/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2014
• 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): Hospitalization