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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Fever (1858); Urinary Retention (2119); Discomfort (2330); Dysuria (2684)

Event Date 01/12/2015

Event Type  Injury  

Event Description

A medical assistant reported that a (b)(6) year old male 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) 2015, the patient received solesta.Prophylactic antibiotics were not administered prior to implantation.On that same date, the patient experienced a fever and "not urinating as well".The patient was evaluated by his physician on (b)(6) 2014 and treatment began with acetaminophen/oxycodone and amoxicillin clavulanate.The patient was again seen by his physician on (b)(6) 2015 with complaints of rectal discomfort.On (b)(6) 2015, the patient was hospitalized for cellulitis in the rectal and urinary retention.While hospitalized, the patient received intravenous antibiotics and a foley catheter was inserted to treat the urinary retention.On (b)(6) 2015, the patient was discharged.The events were considered completely resolved on an unspecified date.The reporter felt the events were possibly related to the use of solesta.The company assessed the events as possibly related to solesta.

Manufacturer Narrative

A causal relation between the events and the treatment cannot be excluded.Although we do not understand why the patient developed urinary retention.Did the patient have a predisposition, e.G.Prostatic hypertrophy? lot number has not been reported and trending on batch cannot be performed.The case has been assessed as serious and fulfills criteria for reporting.

• Brand Name: SOLESTA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4553855
• MDR Text Key: 16307254
• Report Number: 3009325614-2015-00011
• 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
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 02/25/2015,02/06/2015

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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2015
• Distributor Facility Aware Date: 02/06/2015
• Date Report to Manufacturer: 02/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2015
• 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; Required Intervention
• Patient Age: 78 YR