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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Abscess (1690)

Event Date 01/01/2014

Event Type  Injury  

Event Description

A physician reported via a sales representative that a (b)(6) male received solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal as treatment for "horrible" fecal incontinence.Additional medical history included that solesta was considered the "last resort" before having to perform a colostomy.Concurrent medications were not provided.On (b)(6) 2014, the patient received solesta.No antibiotics were administered prophylactically.The patient began having symptoms of an infection soon after solesta injection (timeframe not indicated).He was diagnosed with an abscess and antibiotics were started.The patient did not improve and was evaluated by a gastrointestinal specialist.A flexible sigmoidoscopy was performed; however, the abscess was not drained.The patient was still not improving, so he was seen by a surgeon who observed the infection to be tracking into the patient's pelvis.The patient was taken to the operating room and a colostomy was performed.At the time of this report, the patient was stable and recovering from the events.Causality was not reported.The company felt the events were possibly related to solesta.

Manufacturer Narrative

The limited information about the patient's possible underlying condition makes a causality assessment difficult, however, a causality cannot be excluded.The injection procedure per se and the fact that no prophylactic antibiotics were provided may have contributed to the events.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala 0000 ; SW 0000
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala 752 28; SW 752 28
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3763219
• MDR Text Key: 17161841
• Report Number: 3009325614-2014-00015
• 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: 04/07/2014,03/17/2014

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: 04/07/2014
• Distributor Facility Aware Date: 03/17/2014
• Date Report to Manufacturer: 03/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2014
• 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): Required Intervention
• Patient Age: 80 YR