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

Device Problem Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Discharge (2225); Discomfort (2330); Obstruction/Occlusion (2422)

Event Date 08/01/2013

Event Type  Injury  

Event Description

A (b)(6) year old, nurse practitioner reported that she received solesta (dextranomer/hyaluroinc acid) injection into the submucosa of the anal canal as treatment for fecal incontinence.Additional medical history included hypertension and allergies to morphine and oxycodone/acetaminophen.Concurrent medication was atenolol.On (b)(6) 2013, the patient received solesta.Following the procedure, she experienced abdominal pain.On (b)(6) 2013, the patient developed pressure in her rectum.On (b)(6) 2013, she experienced an itchy anus an a bulge on the posterior wall of the vagina causing three-quarters of her vaginal opening to be occluded.On (b)(6) 2013, the patient was examined by her physician.The bulge inside her vagina "could be" a hematoma.As of (b)(6) 2013, the bulge was still present, hard, and felt like a mass and not fluid.The evens were unchanged at the time of this report.The reporter felt the events were related to the use of solestra.Follow-up received on (b)(6) 2014, via a maude event report and on (b)(6) 2014 from the patient.Four injections of solesta were given of 1 ml each.The injection on the midline of the anterior wall was very painful and bled profusely following the injection.Pressure was applied by the general surgeon to the site.Following the procedure, the patient experienced, in addition to the previously reported events, a mucous discharge from her rectum.Upon experiencing the bulge in her vagina, the patient contacted her surgeon who felt it could be a hematoma and would resolve on its own.On unknown date, she was examined by the surgeon and informed it was "most likely" a hematoma.The patient had follow-up appointments with the surgeon three times over the course of a 3-4 month period.By this time, the patient was experiencing pressure on her bladder and incomplete urination as a result of the mass which had become bigger.The surgeon wanted to remove the solesta implant.The patient sough a second opinion with a urogynecologist.Magnetic resonance imaging (mri) was performed on (b)(6) 2014.It was showed two injections in the rectum an two injections in the vagina which appeared to have combined into a single mass (4x4 cm).An ultrasound was planned for the future.As the urogynecologist felt the mass needed to be surgically removed, that physician requested the patient consult with a colorectal surgeon.The patient's appointment will be on (b)(6) 2014 with the colorectal surgeon.Presently, the patient is experiencing an odor in her vagina and the physician prescribed an estrogen cream.The events were ongoing at the time of this report.The company felt the evens were possible related to solestra.

Manufacturer Narrative

A causal relationship between the treatment and events cannot be excluded.The injection procedure may have contributed to the events.

• Brand Name: SOLESTRA
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala 0000 752 ; SW 0000752 2
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3763220
• MDR Text Key: 4464611
• Report Number: 3009325614-2013-00039
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2014,08/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2014
• Distributor Facility Aware Date: 08/05/2013
• Date Report to Manufacturer: 03/26/2014
• Date Manufacturer Received: 03/19/2014
• 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: ATENOLOL
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73