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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Hematoma (1884); Pain (1994)

Event Date 06/05/2014

Event Type  Injury  

Event Description

A physician reported via a sales rep that a (b)(6) male received solesta (dextranomer/hyaluronic acid) injection into the submucosa of the anal canal as treatment or fecal incontinence.Additional medical history included solesta on (b)(6) 2014 without problems.Concurrent medications were not provided.On (b)(6) 2014, the pt received solesta.On (b)(6) 2014, the pt experienced pain in the rectal area and was advised by his physician to begin tub soaks.The pain continued to progress over the weekend and on (b)(6) 2014, he was evaluated in the physician's office.The pt was diagnosed with a hematoma and a possible abscess.The hematoma was evacuated and 8-10cc of clot were obtained.The area was incised and left open to drain with a sterile dressing applied.In addition, a culture was performed which showed light escherichia coli growth.The pt was begun on ciprofloxacin and metronidazole.Instructions included continued tub soaks and he was prescribed acetaminophen/hydrocodone for the pain.The reporting nurse at the physician's office felt the events were serious as they necessitated medical/surgical intervention and that the events were possibly related to solesta.She went on to explain that it could have been a coincidence that the pt developed an abscess as he did not experience problems with the prior solesta implant.It was possible that the abscess had been drawing and may have flared up after the injection; however, solesta could not be ruled out as the cause of the events.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 the batch number is not available.

• Brand Name: SOLESTA
• Type of Device: AGENT, 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 dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3975083
• MDR Text Key: 4749597
• Report Number: 3009325614-2014-00035
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2014,06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• 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: 07/09/2014
• Distributor Facility Aware Date: 06/20/2014
• Date Report to Manufacturer: 06/30/2014
• Date Manufacturer Received: 06/20/2014
• 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: 73 YR