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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Abscess (1690); Abdominal Distention (2601)

Event Date 11/22/2013

Event Type  Injury  

Event Description

A (b)(6) yr old female rec'd solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal as treatment for fecal incontinence.Add'l medical history included aortic regurgitation, fibromyalgia, and interstim ((b)(6) 2013).Concurrent medications were duloxetine, gabapentin, and multivitamins.On (b)(6) 2013, the pt rec'd solesta.She immediately experienced abdominal bloating and a rectal abscess on (b)(6) 2013, the pt underwent surgery to repair the rectal abscess.The pt has continued to experience severe pain from the rectal abscess.On a pain scale of 1-10, her pain was reported as an 8 or 9.She has been taking oxycodone with no improvement.The outcome was unchanged at the time of this report.The company felt the events were possibly related to solesta.

Manufacturer Narrative

A causal relation between the events and the treatment seems possible.The injection technique or the injection per se may also have contributed to the event.The reported events are addressed in the label.Lot number was not reported and trending on batch cannot be performed.

• Brand Name: SOLESTA
• Type of Device: AGEN, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala SE-7 52 2; SW SE-752 28
• Manufacturer Contact: 8510 colonnade center drive; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3590755
• MDR Text Key: 4186080
• Report Number: 3009325614-2014-00001
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2014,12/23/2013

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2014
• Distributor Facility Aware Date: 12/23/2013
• Date Report to Manufacturer: 01/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2014
• 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
• Treatment: GABAPENTIN; MULTIVITAMINS; CYMBALTA
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 54